8Infection and microbial contamination

Schedule 1—Essential principles (regulation 2.1) ## Part 1—General principles #### 1 Use of medical devices not to compromise health and safety A medical device is to be designed and produced in a way that ensures that: (a) the device will not compromise the clinical condition or safety of a patient, or the safety and health of the user or any other person, when the device is used on a patient under the conditions and for the purposes for which the device was intended and, if applicable, by a user with appropriate technical knowledge, experience, education or training; and (b) any risks associated with the use of the device are: (i) acceptable risks when weighed against the intended benefit to the patient; and (ii) compatible with a high level of protection of health and safety. #### 2 Design and construction of medical devices to conform with safety principles (1) The solutions adopted by the manufacturer for the design and construction of a medical device must conform with safety principles, having regard to the generally acknowledged state of the art. (2) Without limiting subclause (1), in selecting appropriate solutions for the design and construction of a medical device so as to minimise any risks associated with the use of the device, the manufacturer must: (a) first, identify hazards and associated risks arising from the use of the device for its intended purpose, and foreseeable misuse of the device; and (b) second, eliminate, or reduce, these risks as far as possible by adopting a policy of inherently safe design and construction; and (c) third, if appropriate, ensure that adequate protection measures are taken, including alarms if necessary, in relation to any risks that cannot be eliminated; and (d) fourth, inform users of any residual risks that may arise due to any shortcomings of the protection measures adopted. (3) In paragraph (2)(d): > residual risk, for a medical device, means the risk remaining after the measures described in paragraphs (2)(a), (b) and (c) have been applied. #### 3 Medical devices to be suitable for intended purpose A medical device must: (a) perform in the way intended by the manufacturer; and (b) be designed, produced and packaged in a way that ensures that it is suitable for one or more of the purposes mentioned in the definition of medical device in subsection 41BD(1) of the Act. #### 4 Long‑term safety A medical device must be designed and produced in a way that ensures that if: (a) the device is used within the period, indicated by the manufacturer, in which the device can be safely used; and (b) the device is not subjected to stresses that are outside the stresses that can occur during normal conditions of use; and (c) the device is regularly maintained and calibrated in accordance with the manufacturer’s instructions; the characteristics and performances mentioned in clauses 1, 2 and 3 are not adversely affected. #### 5 Medical devices not to be adversely affected by transport or storage A medical device must be designed, produced and packed in a way that ensures that the characteristics and performance of the device when it is being used for its intended purpose will not be adversely affected during transport and storage that is carried out taking account of the instructions and information provided by the manufacturer. #### 6 Benefits of medical devices to outweigh any undesirable effects The benefits to be gained from the use of a medical device for the performance intended by the manufacturer must outweigh any undesirable effects arising from its use. ## Part 2—Other principles #### 7 Chemical, physical and biological properties #### 7.1 Choice of materials In ensuring that the requirements of Part 1 are met in relation to a medical device, particular attention must be given to: (a) the chemical and physical properties of the materials used in the device; and (b) the compatibility between the materials used and biological tissues, cells, body fluids and specimens; having regard to the intended purpose of the device. #### 7.2 Minimisation of risks associated with contaminants and residues (1) A medical device must be designed, produced and packed in a way that ensures that any risks associated with contaminants and residues that may affect a person who is involved in transporting, storing or using the device, or a patient, are minimised, having regard to the intended purpose of the device. (2) In minimising risks, particular consideration must be given to the likely duration and frequency of any tissue exposure associated with the transportation, storage or use of the device. #### 7.3 Ability to be used safely with materials etc (1) A medical device must be designed and produced in a way that ensures that the device can be used safely with any material, substance or gas with which the device may come into contact during normal use or use in routine procedures. (2) If the device is intended to be used to administer medicine, it must be designed and produced in a way that ensures that the device: (a) is compatible with the provisions and restrictions applying to the medicine to be administered; and (b) allows the medicine to perform as intended. #### 7.4 Verification of incorporated substance (1) If a medical device incorporates, or is intended to incorporate, as an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device: (a) the safety and quality of the substance must be verified in accordance with the requirements for medicines; and (b) the ancillary action of the substance must be verified having regard to the intended purpose of the device. (2) For the purposes of this clause, any stable derivative of human blood or human plasma is considered to be a medicine. #### 7.5 Minimisation of risks associated with leaching substances A medical device must be designed and produced in a way that ensures that any risks associated with substances that may leach from the device are minimised. #### 7.6 Minimisation of risks associated with ingress or egress of substances A medical device must be designed and produced in a way that ensures that any risks associated with unintentional ingress of substances into, or unintentional egress of substances out of, the device are minimised, having regard to the nature of the environment in which the device is intended to be used. #### 7.7 Minimisation of risks associated with nanomaterials (1) A medical device must be designed and produced in a way that ensures that any risks associated with the size and the properties of particles which are, or can be, released into a patient’s or user’s body are minimised. (2) In minimising risks, particular attention must be given to the use of nanomaterials. (3) Subclause (1) does not apply to particles that come into contact with intact skin only. #### 8 Infection and microbial contamination #### 8.1 Minimisation of risk of infection and contamination (1) A medical device must be designed and produced in a way that ensures that the risk of infection to a patient, a user, or any other person, is eliminated or minimised. (2) The device must be designed in a way that: (a) allows it to be easily handled; and (b) if appropriate, minimises contamination of the device or specimen by the patient, user or other person; and (c) if appropriate, minimises contamination of the patient, user or other person by the device or specimen. #### 8.2 Control of animal, microbial or recombinant tissues, tissue derivatives, cells and other substances (1) This clause applies in relation to a medical device that contains: (a) tissues, tissue derivatives, cells or substances of animal origin that have been rendered non‑viable; and (b) tissues, tissue derivatives, cells or substances of microbial or recombinant origin. (2) If the tissues, tissue derivatives, cells or substances originated from animals, the animals must have been subjected to appropriate veterinary controls and supervision, having regard to the intended use of the tissues, tissue derivatives, cells or substances. (3) If the medical device contains tissues, tissue derivatives, cells or substances of animal origin, a record must be kept of the country of origin of each animal from which the tissues, tissue derivatives, cells or substances originated. (4) The processing, preservation, testing and handling of tissues, tissue derivatives, cells or substances of animal, microbial or recombinant origin must be carried out in a way that ensures the highest standards of safety for a patient, the user of the device, and any other person. (5) In particular, the production process must implement validated methods of elimination, or inactivation, in relation to viruses and other transmissible agents. > Note: This may not apply to certain IVD medical devices if the characteristics mentioned in subclause 8.2(5) are integral to the intended purpose of the IVD medical device. #### 8.3 Medical devices to be supplied in a sterile state (1) This clause applies in relation to a medical device that is intended by the manufacturer to be supplied in a sterile state. (2) The device must be designed, produced and packed in a way that ensures that the device is sterile when it is supplied, and will remain sterile, if stored and transported in accordance with the directions of the manufacturer, until the protective packaging is opened or damaged. (3) The device must be produced and sterilised using an appropriate validated method. (4) The device must be produced in appropriately controlled conditions. #### 8.4 Medical devices to be supplied in a non‑sterile state (1) A medical device that is intended by the manufacturer to be supplied in a non‑sterile state must be packed in a way that ensures that the device maintains the level of cleanliness stipulated by the manufacturer. (2) If the device is intended to be sterilised before it is used, the device must be packed in a way that: (a) ensures that the risk of microbial contamination is minimised; and (b) is suitable, having regard to the method of sterilisation that the manufacturer indicates is to be used for the device. (3) The device must be produced in appropriately controlled conditions. #### 8.5 Distinction between medical devices supplied in sterile and non‑sterile state If a medical device is supplied in both a sterile state and a non‑sterile state, the information provided with the device must clearly indicate whether the device is in a sterile state or a non‑sterile state. #### 9 Construction and environmental properties #### 9.1 Medical devices intended to be used in combination with other devices or equipment A medical device that is intended by the manufacturer to be used in combination with another medical device or other equipment (including a connection system) must be designed and produced in a way that ensures that: (a) the medical device, and any other device or equipment with which it is used, operate in a safe way; and (b) the intended performance of the device, and any other device or equipment with which it is used, is not impaired. #### 9.2 Minimisation of risks associated with use of medical devices A medical device must be designed and produced in a way that ensures that, as far as practicable, the following risks are removed or minimised: (a) the risk of injury arising from the physical features of the device; (b) any risks associated with reasonably foreseeable environmental conditions; (c) the risk of reciprocal interference involving other devices that are normally used in an investigation or treatment of the kind for which the device is intended to be used; (d) any risks arising if maintenance or calibration of the device is not possible; (e) any risks associated with the ageing of materials used in the device; (f) any risks associated with loss of accuracy of any measuring or control mechanism of the device; (g) the risk of fire or explosion occurring during normal use of the device, and in the event of a single fault condition, especially if the device is intended to be exposed to flammable substances or substances that can cause combustion; (h) the risks associated with disposal of any waste substances. #### 10 Medical devices with a measuring function (1) A medical device that has a measuring function must be designed and produced in a way that ensures that the device provides accurate, precise and stable measurements within the limits indicated by the manufacturer and having regard to the intended purpose of the device. (2) The measurement, monitoring and display scale of the device must be designed and produced in accordance with ergonomic principles, having regard to the intended purpose of the device. (3) The measurements made by the device must be expressed: (a) in Australian legal units of measurement or be compared to at least one point of reference indicated in Australian legal units of measurement; or (b) if the device measures a physical quantity for which no Australian legal unit of measurement has been prescribed under the National Measurement Act 1960, in units approved in writing by the Secretary for the particular device. #### 11 Protection against radiation #### 11.1 Minimisation of exposure to radiation A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to radiation is minimised, having regard to the levels of radiation required to enable the device to perform its therapeutic and diagnostic functions and the intended purpose of the device. #### 11.2 Medical devices intended to emit radiation (1) This clause applies in relation to a medical device that is intended by the manufacturer to emit hazardous levels of visible or invisible radiation because the emission is necessary for a specific medical purpose, the benefit of which is considered to outweigh the risks inherent in the emission. (2) The device must be designed and produced in a way that ensures that the user can control the level of the emission. (3) The device must be designed and produced in a way that ensures the reproducibility and tolerance of relevant variable parameters. (4) If practicable, the device must be fitted with a visual indicator or an audible warning, or both, that operates if potentially hazardous levels of radiation are emitted. #### 11.3 Minimisation of exposure to unintended radiation A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to the emission of unintended, stray or scattered radiation is minimised. #### 11.4 Operating instructions The operating instructions for a medical device that emits radiation must include detailed information about the following matters: (a) the nature of the radiation emitted; (b) the means by which patients and users can be protected from the radiation; (c) ways to avoid misusing the device; (d) ways to eliminate any risks inherent in the installation of the device. #### 11.5 Medical devices intended to emit ionising radiation—additional requirements (1) This clause applies, in addition to clauses 11.1 to 11.4, in relation to a medical device that is intended by the manufacturer to emit ionising radiation. (2) The device must be designed and produced in a way that ensures that, if practicable, the quantity, geometry and energy distribution (or quality) of radiation emitted can be controlled and varied, having regard to the intended purpose of the device. (3) If the device is intended to be used for diagnostic radiology, the device must be designed and produced in a way that ensures that, when used in relation to a patient for a purpose intended by the manufacturer: (a) the device achieves an appropriate image or output quality for that purpose; and (b) the exposure of the patient, or the user, to radiation is minimised. (4) If the device is intended to be used for therapeutic radiology, the device must be designed and produced in a way that ensures that the delivered dose of radiation, the type and energy of the radiation beam and, if appropriate, the energy distribution of the radiation beam, can be reliably controlled and monitored. #### 12 Medical devices connected to or equipped with an energy source #### 12.1 Programmed or programmable medical device or software that is a medical device (1) A programmed or programmable medical device, or software that is a medical device, that is intended to make use of either or both of data and information must be designed and produced in a way that ensures that: (a) the safety, performance, reliability, accuracy, precision, useability, security and repeatability of the device are appropriate for the intended purpose of the device; and (b) any consequent risks, or impairment of performance, associated with one or more fault conditions is eliminated or appropriately reduced; and (c) the device is resilient with respect to interactions that could occur during the use of the device and that could result in unsafe performance of the device; and (d) if relevant to the safety of a patient, or the safety and health of the user or any other person, the device provides suitable warnings in a timely manner: (i) following the disruption to services upon which the device is dependent for the device’s operation; and (ii) following the performance of the device being adversely affected; and (e) if relevant to the safety of a patient, or the safety and health of the user or any other person, the device provides a means by which the user can verify correct operation of the device; and (f) if relevant to the safety of a patient, or the safety and health of the user or any other person, the integrity and quality of the data or information is maintained; and (g) if relevant, the privacy of the data or information is maintained. (2) A programmed or programmable medical device, or software that is a medical device, must be developed, produced and maintained having regard to the generally acknowledged state of the art (including for design, development life cycle, development environment, version control, quality and risk management, security, verification and validation, change and configuration management and problem resolution). (3) A programmed or programmable medical device, or software that is a medical device, that is intended to be used in combination with computing platforms must be designed and developed taking into account the capability, resources and configuration of the platforms and the external factors (including information technology environments) related to the use of the platforms. (4) The manufacturer of a programmed or programmable medical device, or software that is a medical device, must provide instructions or information with the device that sets out requirements (including requirements about hardware, software, information technology environments and security measures) necessary to operate the device as intended. (5) A programmed or programmable medical device, or software that is a medical device, must be designed, produced and maintained with regard to best practice in relation to software, security and engineering to provide cybersecurity of the device, including where appropriate the following: (a) protection against unauthorised access, unauthorised influence or unauthorised manipulation; (b) minimisation of risks associated with known cybersecurity vulnerabilities (including either or both of remediation of known vulnerabilities and application of compensating controls); (c) facilitation of the application of updates, patches, compensating controls and other improvements; (d) disclosure of known vulnerabilities in the device or its components and associated mitigations; (e) making available sufficient information for a user to make decisions with respect to the safety of applying, or not applying, updates, patches, compensating controls and other improvements. (6) The manufacturer of a programmed or programmable medical device, or software that is a medical device, having regard to the intended purpose of the device, the generally acknowledged state of the art and best practice, must ensure that the data that influences the performance of the device is: (a) representative; and (b) of sufficient quality; and (c) maintained to ensure integrity; and (d) managed to reduce bias. #### 12.2 Safety dependent on internal power supply (1) This clause applies in relation to a medical device if the safety of a patient on whom the device is to be used will depend on an internal power supply for the device. (2) The device must be fitted with a means of determining the state of the power supply. #### 12.3 Safety dependent on external power supply (1) This clause applies in relation to a medical device if the safety of a patient on whom the device is to be used will depend on an external power supply for the device. (2) The device must be fitted with an alarm system that indicates whether a power failure has occurred. #### 12.4 Medical devices intended to monitor clinical parameters A medical device that is intended by the manufacturer to be used to monitor one or more clinical parameters of a patient must be fitted with an appropriate alarm system to warn the user if a situation has developed that could lead to the death of the patient or a severe deterioration in the state of the patient’s health. #### 12.5 Minimisation of risk of electromagnetic fields A medical device must be designed and produced in a way that ensures that the risk of an electromagnetic field being created that could impair the operation of other devices or equipment being used in the vicinity of the medical device is minimised. #### 12.6 Protection against electrical risks A medical device must be designed and produced in a way that ensures that, as far as possible, when the device is installed correctly, and the device is being used for an intended purpose under normal conditions of use and in the event of a single fault condition, patients, users, and any other persons, are protected against the risk of accidental electric shock. #### 12.7 Protection against mechanical risks A medical device must be designed and produced in a way that ensures that a patient, the user, and any other person, is protected against any mechanical risks associated with the use of the device. #### 12.8 Protection against risks associated with vibration (1) A medical device must be designed and produced in a way that ensures that any risks associated with vibrations generated by the device are minimised. (2) If vibrations are not part of the intended performance of the device, particular attention must be given to relevant technical progress, and the available means, for limiting vibrations, particularly at source. #### 12.9 Protection against risks associated with noise (1) A medical device must be designed and produced in a way that ensures that any risks associated with noise emitted by the device are minimised. (2) If noise is not part of the intended performance of the device, particular attention must be given to relevant technical progress, and the available means, for reducing the emission of noise, particularly at source. #### 12.10 Protection against risks associated with terminals and connectors A medical device that is intended by the manufacturer to be connected to an electric, gas, hydraulic, pneumatic or other energy supply must be designed and produced in a way that ensures that any risks to the user associated with the handling of a terminal or connector on the device, in relation to the energy supply, are minimised. #### 12.11 Protection against risks associated with heat A medical device must be designed and produced in a way that ensures that, during normal use, any accessible part of the device (other than any part intended by the manufacturer to supply heat or reach a given temperature), and any area surrounding an accessible part of the device, does not reach a potentially dangerous temperature. #### 12.12 Protection against risks associated with administration of energy or substances (1) This clause applies in relation to a medical device that is intended by the manufacturer to be used to administer energy or a substance to a patient. (2) The device must be designed and produced in a way that ensures that: (a) the delivered rate and amount of energy, or of the substance, can be set and maintained accurately to ensure the safety of the patient and the user; and (b) as far as possible, the accidental release of dangerous levels of energy or of the substance is prevented. (3) The device must be fitted with a means of indicating or, if appropriate, preventing inadequacies in the rate and amount of energy, or of the substance, administered that might cause danger to the patient, the user or any other person. (4) The functions of each control and indicator on the device must be clearly specified on the device. (5) If the instructions for the operation of the device, or the operating or adjustment parameters for the device, are displayed by means of a visual system incorporated into the device, the instructions or parameters must be able to be understood by the user and, if appropriate, the patient. #### 12.13 Active implantable medical devices (1) An active implantable medical device must incorporate, display, emit or exhibit a code or unique characteristic that can be used to identify: (a) the type of device; and (b) the manufacturer of the device; and (c) the year of manufacture of the device. (2) The code or unique characteristic must be able to be read without the need for surgery to the person in whom the device is implanted. #### 13 Information to be provided with medical devices #### 13.1 Information to be provided with medical devices—general (1) The following information must be provided with a medical device: (a) information identifying the device; (b) information identifying the manufacturer of the device; (c) information explaining how to use the device safely; having regard to the training and knowledge of potential users of the device. (2) In particular: (a) the information required by clause 13.3 must be provided with a medical device; and (b) if instructions for use of the device are required under subclause 13.4, the information mentioned in subclause 13.4(3) must be provided in those instructions. (3) The information: (a) must be provided in English; and (b) may also be provided in any other language. > Note: The information may also include diagrams or drawings. (4) The format, content and location of the information must be appropriate for the device and its intended purpose. (5) Any number, letter, symbol, or letter or number in a symbol, used in the information must be legible and at least 1 millimetre high. (6) If a symbol or identification colour that is not included in a medical device standard is used in the information provided with the device, or in the instructions for use of the device, the meaning of the symbol or identification colour must be explained in the information provided with the device or the instructions for use of the device. #### 13.2 Information to be provided with medical devices—location (1) Unless it is impracticable or inappropriate to do so, the information required to be provided with a medical device must be provided on the device itself. (2) If it is not practicable to comply with subclause (1) in relation to the provision of the information, the information must be provided: (a) on the packaging used for the device; or (b) in the case of devices that are packaged together because individual packaging of the devices for supply is not practicable—on the outer packaging used for the devices. (3) If it is not practicable to comply with subclause (1) or (2) in relation to the provision of the information required under subregulation 10.2(1) or clause 13.3: (a) for a medical device that is not software—the information must be provided on a leaflet supplied with the device; or (b) for a medical device that is software—the information must be provided on a leaflet supplied with the device or the information must be provided electronically. (4) If it is not practicable to comply with subclause (1) or (2) in relation to the provision of the information required under clause 13.4, the information must be provided in a printed document or using other appropriate media. #### 13.3 Information to be provided with medical devices—particular requirements The information mentioned in the following table must be provided with a medical device. | Item | Information to be provided | | ---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 1 | The manufacturer’s name, or trading name, and address | | 2 | The intended purpose of the device, the intended user of the device, and the kind of patient on whom the device is intended to be used (if this information is not obvious) | | 3 | Sufficient information to enable a user to identify the device, or if relevant, the contents of packaging | | 4 | Any particular handling or storage requirements applying to the device | | 5 | Any warnings, restrictions, or precautions that should be taken, in relation to use of the device | | 6 | Any special operating instructions for the use of the device | | 7 | If applicable, an indication that the device is intended for a single use only | | 8 | If applicable, an indication that the device has been custom‑made for a particular individual or health professional and is intended for use only by that individual or health professional | | 9 | If applicable, an indication that:(a) if the device is a medical device other than an IVD medical device—the device is intended for pre‑market clinical investigation; or(b) if the device is an IVD medical device—the device is intended for performance evaluation only | | 10 | For a sterile device, the word ‘STERILE’ and information about the method that was used to sterilise the device | | 11 | The batch code, lot number or serial number of the device | | 12 | If applicable, a statement of the date (expressed in a way that clearly identifies the month and year) up to when the device can be safely used | | 13 | If the information provided with the device does not include the information mentioned in item 12—a statement of the date of manufacture of the device (this may be included in the batch code, lot number or serial number of the device, provided the date is clearly identifiable) | | 14 | If applicable, the words ‘for export only’ | > Note: In addition to the information mentioned in the above table, regulation 10.2 requires certain information to be provided with a medical device. #### 13.4 Instructions for use (1) Instructions for the use of a medical device must be provided with the device. (2) However, instructions for the use of a medical device need not be provided with the device, or may be abbreviated, if: (a) the device is a Class I medical device, a Class IIa medical device or a Class 1 IVD medical device; and (b) the device can be used safely for its intended purpose without instructions. (3) Instructions for the use of a medical device must include information mentioned in the following table that is applicable to the device. | Item | Information to be provided | | ---- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 1 | The manufacturer’s name, or trading name, and address | | 2 | The intended purpose of the device, the intended user of the device, and the kind of patient on whom the device is intended to be used | | 3 | Information about any risk arising because of other equipment likely to be present when the device is being used for its intended purpose (for example, electrical interference from electro‑surgical devices or magnetic field interference from magnetic resonance imaging devices) | | 4 | Information about the intended performance of the device and any undesirable side effects caused by use of the device | | 5 | Any contra‑indications, warnings, restrictions, or precautions that may apply in relation to use of the device | | 6 | Sufficient information to enable a user to identify the device, or if relevant, the contents of packaging | | 7 | Any particular handling or storage requirements applying to the device | | 8 | If applicable, an indication that the device is intended for a single use only | | 9 | If applicable, an indication that the device has been custom‑made for a particular individual or health professional and is intended for use only by that individual or health professional | | 10 | If applicable, an indication that:(a) if the device is a medical device other than an IVD medical device—the device is intended for pre‑market clinical investigation; or(b) if the device is an IVD medical device—the device is intended for performance evaluation only | | 11 | For a sterile device, the word ‘STERILE’ and information about the method that was used to sterilise the device | | 12 | For a device that is intended by the manufacturer to be supplied in a sterile state:(a) an indication that the device is sterile; and(b) information about what to do if sterile packaging is damaged; and(c) if appropriate, instructions for resterilisation of the device | | 13 | For a medical device that is intended by the manufacturer to be sterilised before use—instructions for cleaning and sterilising the device which, if followed, will ensure that the device continues to comply with the applicable provisions of the essential principles | | 14 | Any special operating instructions for the use of the device | | 15 | Information to enable the user to verify whether the device is properly installed and whether it can be operated safely and correctly, including details of calibration (if any) needed to ensure that the device operates properly and safely during its intended life | | 16 | Information about the nature and frequency of regular and preventative maintenance of the device, including information about the replacement of consumable components of the device during its intended life | | 17 | Information about any treatment or handling needed before the device can be used | | 18 | For a device that is intended by the manufacturer to be installed with, or connected to, another medical device or other equipment so that the device can operate as required for its intended purpose—sufficient information about the device to enable the user to identify the appropriate other medical device or equipment that will ensure a safe combination | | 19 | For an implantable medical device—information about any risks associated with its implantation | | 20 | For a reusable device:(a) information about the appropriate processes to allow reuse of the device (including information about cleaning, disinfection, packaging and, if appropriate, resterilisation of the device); and(b) an indication of the number of times the device may be safely reused | | 21 | For a medical device that is intended by the manufacturer to emit radiation for medical purposes—details of the nature, type, intensity and distribution of the radiation emitted | | 22 | Information about precautions that should be taken by a patient and the user if the performance of the device changes | | 23 | Information about precautions that should be taken by a patient and the user if it is reasonably foreseeable that use of the device will result in the patient or user being exposed to adverse environmental conditions | | 24 | Adequate information about any medicinal product that the device is designed to administer, including any limitations on the substances that may be administered using the device | | 25 | Information about any medicine (including any stable derivative of human blood or blood plasma) that is incorporated, or is intended to be incorporated, into the device as an integral part of the device | | 25A | For a medical device to which clause 5.5 of Schedule 2 applies (other than an IVD medical device), information to the effect that the device contains or incorporates any of the following:(a) non‑viable tissues, or cells, of animal origin;(b) derivatives of tissues or cells referred to in paragraph (a). | | 26 | Information about precautions that should be taken by a patient and the user if there are special or unusual risks associated with the disposal of the device | | 27 | Information about the degree of accuracy claimed if the device has a measuring function | | 28 | Information about any particular facilities required for use of the device or any particular training or qualifications required by the user of the device | | 29 | For an IVD medical device, information (including, to the extent practicable, drawings and diagrams) about the following:(a) the scientific principle (the ‘test principle’) on which the performance of the IVD medical device relies;(b) specimen type, collection, handling and preparation;(c) reagent description and any limitations (for example, use with a dedicated instrument only); | | | (d) assay procedure including calculations and interpretation of results;(e) interfering substances and their effect on the performance of the assay; | | | (f) analytical performance characteristics, such as sensitivity, specificity, accuracy and precision;(g) clinical performance characteristics, such as sensitivity and specificity;(h) reference intervals, if appropriate;(i) any precautions to be taken in relation to substances or materials that present a risk of infection | | 30 | For an adaptable medical device, instructions for assembling or adapting the device which, if followed, will ensure that the device continues to comply with the applicable provisions of the essential principles | | 31 | For a medical device production system, instructions for the process to be followed in producing the medical device the system is intended to produce which, if followed, will ensure that the device so produced will comply with the applicable provisions of the essential principles | #### 13.5 UDI medical devices—UDI device identifier and UDI production identifier (1) For a UDI medical device, the UDI device identifier, and the UDI production identifier, of the UDI medical device must be provided with the UDI medical device in accordance with this clause. General rule (2) Subject to this clause: (a) subject to paragraphs (b) and (c), each identifier, in human‑readable form and machine‑readable form, must be provided on the UDI medical device itself; or (b) subject to paragraph (c), if it is impracticable or inappropriate to comply with paragraph (a), each identifier, in human‑readable form and machine‑readable form: (i) must be provided on the packaging used for the UDI medical device, unless subparagraph (ii) applies; or (ii) if the UDI medical device is packaged together with other such UDI medical devices because individual packaging of the UDI medical devices for supply is not practicable—must be provided on the outer packaging used for the UDI medical devices; or (c) if it is impracticable or inappropriate to comply with paragraphs (a) and (b)—each identifier, in human‑readable form and machine‑readable form: (i) if the UDI medical device is not software—must be provided on a leaflet supplied with the UDI medical device; or (ii) if the UDI medical device is software—must be provided on a leaflet supplied with the UDI medical device or must be provided electronically. UDI medical device to which clause 13C.5 applies (3) For a UDI medical device to which clause 13C.5 applies, on and after the direct marking start day for the UDI medical device, subclause (2) of this clause ceases to apply in relation to the UDI medical device. Instead: (a) subject to paragraph (b), each identifier, in human‑readable form and machine‑readable form: (i) must be provided on the packaging used for the UDI medical device, unless subparagraph (ii) applies; or (ii) if the UDI medical device is packaged together with other such UDI medical devices because individual packaging of the UDI medical devices for supply is not practicable—must be provided on the outer packaging used for the UDI medical devices; or (b) if it is impracticable or inappropriate to comply with paragraph (a)—each identifier, in human‑readable form and machine‑readable form, must be provided on a leaflet supplied with the UDI medical device. Qualification for UDI medical device intended by manufacturer to be supplied at retail premises (4) For a UDI medical device that is intended by the manufacturer to be supplied at retail premises, the UDI production identifier of the UDI medical device, in machine‑readable form, is not required to be provided with the UDI medical device. #### 13.6 UDI medical devices—medical device packaging identifier (1) If a type of packaging is used for a UDI medical device, the medical device packaging identifier of that packaging must be provided with the UDI medical device. (2) That identifier, in human‑readable form and machine‑readable form, must be provided on the packaging of the UDI medical device. #### 13A Patient information about implantable medical devices or active implantable medical devices to be made available #### 13A.1 Scope of clauses 13A.2 to 13A.4 (1) Clauses 13A.2 to 13A.4 apply to a medical device that is: (a) an implantable medical device or an active implantable medical device; and (b) not a suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip, connector or similar article; and (ba) not intended by the manufacturer to be for export only; and (c) not a medical device to which subclause (2) applies. (2) This subclause applies to a medical device if: (a) the medical device is intended by the manufacturer to be wholly, or mostly, absorbed by a patient’s body within 6 months of being implanted; and (b) the medical device is: (i) for use as a filler; or (ii) for haemostasis; or (iii) for tissue approximation; or (iv) for the fixation of other medical devices within tissue; or (v) a similar medical device to a medical device covered by subparagraph (i), (ii), (iii) or (iv). #### 13A.2 Patient implant cards etc. for implantable devices (1) Either: (a) a card (a patient implant card) that: (i) in any case—includes the information covered by subclause (2) and that satisfies clause 13A.4; and (ii) for a UDI medical device—includes the UDI device identifier, and the UDI production identifier, of the UDI medical device (where each identifier is in human‑readable form and machine‑readable form); must be made available for provision to the patient concerned; or (b) the following: (i) in any case—information covered by subclause (2) and that satisfies clause 13A.4; (ii) for a UDI medical device—the UDI device identifier, and the UDI production identifier, of the UDI medical device (where each identifier is in human‑readable form and machine‑readable form); must be made available electronically and in a way that is readily accessible by the patient concerned. (2) The information covered by this subclause is the information in the following table. ```html <table cellspacing="0" cellpadding="0" style="width:426.95pt; border-collapse:collapse"><thead><tr><td colspan="2" style="width:416.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Information to be made available for provision to patient</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Information</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the name of the device; and</span></p><p class="Tablea"><span>(b) the model of the device; and</span></p><p class="Tablea"><span>(c) the batch code, lot number or serial number of the device</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The manufacturer’s name, address and website</span></p></td></tr></thead></table> ``` #### 13A.3 Patient information leaflets etc. for implantable devices (1) Either: (a) a leaflet (a patient information leaflet) that includes the information covered by subclauses (2) and (3) and that satisfies subclause (4) and clause 13A.4 must be made available for provision to the patient concerned; or (b) information covered by subclauses (2) and (3) that is in electronic form and that satisfies subclause (4) and clause 13A.4 must be made available in a way that is readily accessible by the patient concerned. (2) The information covered by this subclause is the following information: (a) information identifying the device, or the kind of device; (b) the intended purpose of the device; (c) information explaining how to use the device safely; (d) other information about the device that the manufacturer considers would be useful for patients. (3) The information covered by this subclause is the information in the following table. ```html <table cellspacing="0" cellpadding="0" style="width:426.95pt; border-collapse:collapse"><thead><tr><td colspan="2" style="width:416.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Information to be made available for provision to patient</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Information</span></p></td></tr></thead><tbody><tr><td style="width:38.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:366.45pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the name of the device; and</span></p><p class="Tablea"><span>(b) the model of the device</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the intended purpose of the device; and</span></p><p class="Tablea"><span>(b) the kind of patient on whom the device is intended to be used</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Any special operating instructions for the use of the device</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the intended performance of the device; and</span></p><p class="Tablea"><span>(b) any undesirable side effects that could be caused by use of the device</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Any residual risks that could arise due to any shortcomings of the protection measures adopted as mentioned in subclause</span><span> </span><span>2(2)</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) warnings about risks that could arise from the interaction of the device with other equipment; and</span></p><p class="Tablea"><span>(b) precautions and other measures that, because of those risks, should be taken by the patient or a health professional</span></p><p class="notemargin"><span>Example 1:</span><span style="width:26.76pt; text-indent:0pt; display:inline-block"> </span><span>The risk of electrical interference from electro</span><span>‑</span><span>surgical devices.</span></p><p class="notemargin"><span>Example 2:</span><span style="width:29.76pt; text-indent:0pt; display:inline-block"> </span><span>The risk of magnetic field interference from magnetic resonance imaging devices.</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the nature and frequency of regular or preventative examination, monitoring or maintenance of the device that should be undertaken; and</span></p><p class="Tablea"><span>(b) symptoms that could indicate that the device is malfunctioning; and</span></p><p class="Tablea"><span>(c) precautions and other measures that should be taken by the patient if the performance of the device changes or the patient experiences any of the symptoms mentioned in paragraph</span><span> </span><span>(b); and</span></p><p class="Tablea"><span>(d) the expected device lifetime; and</span></p><p class="Tablea"><span>(e) anything that could shorten or lengthen the device lifetime; and</span></p><p class="Tablea"><span>(f) precautions and other measures that should be taken at, or near, the end of the expected device lifetime; and</span></p><p class="Tablea"><span>(g) other circumstances in which the patient should contact a health professional in relation to the operation of the device</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the materials and substances included in the device; and</span></p><p class="Tablea"><span>(b) any manufacturing residuals that could pose a risk to the patient</span></p></td></tr><tr><td style="width:38.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:366.45pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the Therapeutic Goods Administration; and</span></p><p class="Tablea"><span>(b) the address of the Therapeutic Goods Administration’s website</span></p></td></tr></tbody></table> ``` (4) The information covered by subclauses (2) and (3) must be written in a way that is readily understood by patients. #### 13A.4 General requirements for information to be made available for patients (1) The information covered by subclause 13A.2(2) or 13A.3(2) or (3): (a) must be included in English; and (b) may also be included in any other language. > Note: The information may also include diagrams or drawings. (2) Any number, letter or symbol, or letter or number in a symbol, that is part of the information covered by subclause 13A.2(2) or 13A.3(2) or (3) must be: (a) legible; and (b) if the number, letter or symbol, or letter or number in a symbol, is included in a patient implant card or patient information leaflet—at least 1 millimetre high. #### 13B Software—version numbers and build numbers (1) For a medical device that is software, or that incorporates software, the current version number and current build number of the software must be accessible by, and identifiable to, users of the device. (2) The current version number and current build number of the software: (a) must be in English; and (b) may also be in any other language. #### 13C Rules for UDI medical devices #### 13C.1 Identifiers relating to UDI medical devices (1) For UDI medical devices that are a type of model, the UDI device identifier of those medical devices must have been issued by a UDI issuing agency. (2) For UDI medical devices that are a type of model, the UDI production identifier of those medical devices must have been allocated by, or on behalf of, the manufacturer in accordance with any applicable requirements of the UDI issuing agency that issued the UDI device identifier of those medical devices. (3) If a type of packaging is used for UDI medical devices that are a type of model, the medical device packaging identifier of that packaging must have been issued by a UDI issuing agency. (4) In relation to UDI medical devices that are a type of model, the identifiers covered by subclauses (1) and (3) must have been issued by the same UDI issuing agency. #### 13C.2 Inclusion of identifiers in the Australian Unique Device Identification Database Inclusion of UDI device identifiers (1) For UDI medical devices that are a type of model: (a) the UDI device identifier of those medical devices must be included in the Australian Unique Device Identification Database; and (b) the name of the UDI issuing agency that issued the UDI device identifier must be included in that database. > Note: Subclause (5) deals with the circumstances in which there is a different type of model of UDI medical devices. The UDI device identifier of the UDI medical devices of the different type of model would then need to be included in that database. Inclusion of medical device package identifiers (2) If a type of packaging is used for UDI medical devices that are a type of model, the medical device packaging identifier of that packaging must be included in the Australian Unique Device Identification Database. Timing of inclusion of information (3) The information covered by subclause (1), for UDI medical devices that are a type of model, must be included in the Australian Unique Device Identification Database before the end of the period of 30 days beginning on the first day, that is on or after the general start day for the UDI medical devices, on which the UDI medical devices are supplied for use in Australia. (4) The information covered by subclause (2), for a type of packaging that is used for UDI medical devices that are a type of model, must be included in the Australian Unique Device Identification Database before the end of the period of 30 days beginning on the first day, that is on or after the general start day for the UDI medical devices, on which the UDI medical devices are supplied for use in Australia with that type of packaging. Different models of medical devices (5) Subject to subclause (6), if a change (a relevant change) of the following kind occurs to or in relation to UDI medical devices that are a type of model, those medical devices, as affected by that change, are taken to be a different type of model: (a) if the medical devices are not labelled as being for a single use only—the medical devices are labelled as being for a single use only; (b) the labels for the medical devices, or information provided with the medical devices, state that the medical devices contain latex; (c) a change to the magnetic resonance imaging safety status of the medical devices; (d) the labels for the medical devices, or information provided with the medical devices, state that the medical devices are packaged in a sterile state; (e) the labels for the medical devices, or information provided with the medical devices, state that the medical devices must be sterilised before use; (f) a change to the clinical size of the medical devices; (g) if the labels for the medical devices, or information provided with the medical devices, refer to a recommended number of reuses of the medical devices—a reduction in that recommended number of reuses; (h) a change to the brand name of the medical devices; (i) a change to the model number or version number of the medical devices; (j) a change to the quantity of the medical devices provided in a package; (k) if the medical devices are software—a change to the features of the software (including the addition of a new feature or a change to an existing feature) that results in a change to the safety, performance or intended purpose of the medical devices. > Note: The medical devices, before the change, remain a type of model. (6) If 2 or more relevant changes occur to or in relation to UDI medical devices that are a type of model as part of the same change in production of those medical devices, those medical devices, as affected by the 2 or more relevant changes, are taken to be a different type of model. (7) Subclause (5) does not limit the circumstances in which there may be a different type of model of UDI medical devices. #### 13C.3 Inclusion of other information in the Australian Unique Device Identification Database (1) For a UDI medical device, the following information must be included in the Australian Unique Device Identification Database: (a) the identification number allocated to the manufacturer by the Therapeutic Goods Administration; (b) the manufacturer’s name or trading name; (c) the brand name of the device; (d) the device number in relation to the device; (e) the model number or version number of the device; (f) any additional identifiers that are associated with the device; (g) any particular handling or storage requirements applying to the device; (h) any warnings, restrictions, or precautions that should be taken, in relation to use of the device; (i) any special operating instructions for the use of the device; (j) the following: (i) whether or not the device is intended for a single use only; (ii) if the device is not intended for a single use only—any restrictions on the number of times the device can be used; (k) if applicable, information about the method to sterilise the device; (l) whether or not a batch code, lot number or serial number is to be provided with the device; (m) whether or not the date of manufacture of the device, or the expiry date of the device, is to be provided with the device; (n) if the device is intended to be used in connection with blood, blood components or blood products—whether or not a donation identification number is able to be provided with the device; (o) whether or not the device is, or incorporates, software; (p) whether or not the device is a type of kit; (q) if the device is intended to be packaged together with UDI medical devices of the same model—the number of medical devices intended to be included in the base package. > Note: For the definition of device number, in relation to a medical device, see subsection 3(1) of the Act. (2) If the clinical size type of a UDI medical device is included in the Australian Unique Device Identification Database, then the clinical size value, and the clinical size unit of measure, of the UDI medical device must also be included in that database. (3) The information required to be included in that database by subclause (1) or (2) must be included in that database before the end of the period of 30 days beginning on the first day, that is on or after the general start day for the UDI medical device, on which the UDI medical device is supplied for use in Australia. #### 13C.4 Information in the Australian Unique Device Identification Database to be accurate and up to date Information included in the Australian Unique Device Identification Database must be accurate and up to date. #### 13C.5 UDI device identifier and UDI production identifier to be directly marked on UDI medical device (1) For UDI medical devices that are a type of model and are intended by the manufacturer to be reprocessed between use on different patients, the UDI device identifier, and the UDI production identifier, of those medical devices: (a) must be directly marked on those medical devices by the manufacturer; and (b) must be directly marked as follows: (i) in human‑readable form and machine‑readable form, unless subparagraph (ii) applies; (ii) if it is impracticable or inappropriate for direct marking in both forms—in human‑readable form or machine‑readable form. (2) Subclause (1) does not apply in relation to UDI medical devices that are a type of model if: (a) those medical devices have been manufactured before the direct marking start day for those medical devices; or (b) those medical devices are implantable medical devices; or (c) the direct marking of the UDI device identifier, and the UDI production identifier, of those medical devices on those medical devices is likely to affect the safety, performance or effectiveness of those medical devices; or (d) it would be impracticable for the manufacturer to directly mark the UDI device identifier, and the UDI production identifier, of those medical devices on those medical devices. #### 14 Clinical evidence Every medical device requires clinical evidence, appropriate for the use and classification of the device, demonstrating that the device complies with the applicable provisions of the essential principles. > Note: See regulation 3.11 and the clinical evaluation procedures. #### 15 Principles applying to IVD medical devices only (1) An IVD medical device must be designed and manufactured in a way in which the analytical and clinical characteristics support the intended use, based on appropriate scientific and technical methods. (2) An IVD medical device must be designed in a way that addresses accuracy, precision, sensitivity, specificity, stability, control of known relevant interference and measurement of uncertainty, as appropriate. (3) If performance of an IVD medical device depends in whole or part on the use of calibrators or control materials, the traceability of values assigned to the calibrators or control material must be assured through a quality management system. (4) An IVD medical device must, to the extent reasonably practicable, include provision for the user to verify, at the time of use, that the device will perform as intended by the manufacturer. (5) An IVD medical device for self‑testing must be designed and manufactured so that it performs appropriately for its intended purpose, taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in the user’s technique and environment. (6) The information and instructions provided by the manufacturer of an IVD medical device for self‑testing must be easy for the user to understand and apply. (7) An IVD medical device for self‑testing must be designed and manufactured in a way that reduces, to the extent practicable, the risk of error in the use of the device, the handling of the sample and the interpretation of results. Schedule 2—Classification rules for medical devices other than IVD medical devices Note: Regulation 3.2 provides for the making of classification rules. Regulation 3.3 sets out the principles for applying those rules. ## Part 1—Interpretation #### 1.1 Transient, short‑term and long‑term use (1) For the purposes of this Schedule: (a) a medical device is intended for transient use if the manufacturer intends the device to be used continuously for less than 60 minutes; and (b) a medical device is intended for short‑term use if the manufacturer intends the device to be used continuously for at least 60 minutes but not more than 30 days; and (c) a medical device is intended for long‑term use if the manufacturer intends the device to be used continuously for more than 30 days. (2) For the purposes of determining whether a medical device is intended to be used continuously, disregard any temporary interruption or removal. > Note: Example: A temporary interruption or removal in order to clean or disinfect the medical device. ## Part 2—Rules for non‑invasive medical devices #### 2.1 Non‑invasive medical devices—general A non‑invasive medical device is classified as Class I, unless the device is classified at a higher level under another clause in this Part or in Part 4 or 5 of this Schedule. #### 2.2 Non‑invasive medical devices intended to channel or store blood, etc (1) This clause applies to: (a) a non‑invasive medical device that is intended by the manufacturer to be used to channel or store blood or body liquids that are to be infused, administered or introduced into a patient; and (b) a non‑invasive medical device that is intended by the manufacturer to be used to store an organ, part of an organ or body tissue that is to be later introduced into a patient; and (c) a non‑invasive medical device that: (i) is intended by the manufacturer to be used to channel or store a liquid or gas that is to be infused, administered or introduced into a patient; and (ii) may be connected to an active medical device classified as Class IIa or higher. (2) The device is classified as Class IIa. #### 2.3 Non‑invasive medical devices intended to modify the biological or chemical composition of blood, etc (1) Subject to subclause (2), a non‑invasive medical device that is intended by the manufacturer to be used to modify the biological or chemical composition of blood, other body liquids, or other liquids intended to be infused into a patient, is classified as Class IIb. (2) If the treatment for which the device is designed consists of filtration, centrifugation or exchanges of gas or heat, the device is classified as Class IIa. #### 2.4 Non‑invasive medical devices intended to have contact with injured skin or mucous membrane (1) This clause applies to a non‑invasive medical device that is intended by the manufacturer to be used in contact with injured skin or a mucous membrane (including a device the principal intention of which is to manage the micro‑environment of a wound). (2) Subject to subclauses (3) and (4), the device is classified as Class IIa. (3) If the device is intended to be used: (a) as a mechanical barrier; or (b) for compression; or (c) for the absorption of exudates; the device is classified as Class I. (4) If the device is intended to be used principally for wounds that have breached the dermis and the wounds can only heal by secondary intent, the device is classified as Class IIb. ## Part 3—Rules for invasive medical devices and implantable medical devices #### 3.1 Invasive medical devices intended to be used by penetration of body orifices (1) This clause applies to an invasive medical device (other than a surgically invasive medical device or a medical device covered by clause 5.10 or 5.11) that is intended by the manufacturer to be used to penetrate a body orifice of a patient. (2) If the device is not intended to be connected to an active medical device, the following rules apply: (a) if the device is intended for transient use, the device is classified as Class I; (b) if the device is intended for short‑term use: (i) the device is classified as Class IIa; or (ii) if the device is intended to be used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum, or in a nasal cavity—the device is classified as Class I; (c) if the device is intended for long‑term use: (i) the device is classified as Class IIb; or (ii) if the device is intended to be used in the oral cavity as far as the pharynx or in an ear canal up to the ear drum, or the device is intended to be used in a nasal cavity and the device is not liable to be absorbed by the skin or mucous membrane—the device is classified as Class IIa. (3) If the device is intended to be connected to an active medical device that is classified as Class IIa or higher, the device is classified as Class IIa. #### 3.2 Surgically invasive medical devices intended for transient use (1) This clause applies to a surgically invasive medical device that is intended for transient use. (2) Subject to subclauses (3) to (5), the device is classified as Class IIa. (3) If the device is intended by the manufacturer specifically to be used to diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body, the device is classified as Class III. (3A) If the device is not a reusable surgical instrument and the device is intended by the manufacturer specifically to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient, the device is classified as Class III. (4) If the device is a reusable surgical instrument, the device is classified as Class I. (5) If: (a) the device is intended by the manufacturer to be used to supply energy in the form of ionising radiation; or (b) the device is intended by the manufacturer to have a biological effect; or (c) the device is intended by the manufacturer to be wholly, or mostly, absorbed by the patient’s body; or (d) the device is intended by the manufacturer to be used to administer medicine to a patient by means of a delivery system, and the administration is potentially hazardous to the patient having regard to the characteristics of the device; the device is classified as Class IIb. #### 3.3 Surgically invasive medical devices intended for short‑term use (1) This clause applies to a surgically invasive medical device that is intended for short‑term use. (2) Subject to subclauses (3) and (4), the device is classified as Class IIa. (3) If: (a) the device is intended by the manufacturer to be used to supply energy in the form of ionising radiation; or (b) the device is intended by the manufacturer to undergo a chemical change in a patient’s body (other than a device that is intended by the manufacturer to be placed in the teeth); or (c) the device is intended by the manufacturer to administer medicine; the device is classified as Class IIb. > Note for paragraph (b): A device that is intended by the manufacturer to be placed in the teeth, and to undergo a chemical change in the body, is classified as Class IIa—see subclause (2). (4) If the device is intended by the manufacturer: (a) specifically to be used to diagnose, monitor, control or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body; or (b) specifically to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient; or (c) to have a biological effect; or (d) to be wholly, or mostly, absorbed by a patient’s body; the device is classified as Class III. (5) For this clause, a medical device that is intended by the manufacturer to be placed in the teeth includes a medical device that is intended by the manufacturer to penetrate a tooth, but does not include a medical device that is intended by the manufacturer to penetrate a tooth and enter the gum or bone beyond the tooth. #### 3.4 Surgically invasive medical devices intended for long‑term use and implantable medical devices (1) This clause applies to: (a) a surgically invasive medical device that is intended for long‑term use; and (b) an implantable medical device. (2) Subject to subclauses (3), (4), (4A) and (4B), the device is classified as Class IIb. (3) If the device is intended by the manufacturer to be placed in the teeth of a patient, the device is classified as Class IIa. (4) If the device is intended by the manufacturer: (a) to be used in direct contact with the heart, the central circulatory system or the central nervous system of a patient; or (b) to have a biological effect; or (c) to be wholly, or mostly, absorbed by a patient’s body; or (d) to undergo a chemical change in a patient’s body (other than a device that is intended by the manufacturer to be placed in the teeth); or (e) to be used to administer medicine; the device is classified as Class III. > Note for paragraph (d): A device that is intended by the manufacturer to be placed in the teeth, and to undergo a chemical change in the body, is classified as Class IIa—see subclause (3). (4A) The device is classified as Class III if it is: (a) a joint replacement medical device; or (b) surgical mesh. (4B) If the device is intended by the manufacturer to be a motion‑preserving device for the spine (such as a spinal disc replacement), the device is classified as Class III. (5) For this clause, a medical device that is intended by the manufacturer to be placed in the teeth includes a medical device that is intended by the manufacturer to penetrate a tooth, but does not include a medical device that is intended by the manufacturer to penetrate a tooth and enter the gum or bone beyond the tooth. ## Part 4—Special rules for active medical devices #### 4.1 Active medical devices—general An active medical device is classified as Class I, unless the device is classified at a higher level under another clause in this Part or in Part 2, 3 or 5. #### 4.2 Active medical devices for therapy (1) Subject to subclause (2), an active medical device for therapy that is intended by the manufacturer to be used to administer energy to a patient, or exchange energy to or from a patient, is classified as Class IIa. (2) If the device is of a kind such that the administration or exchange of energy occurs in a potentially hazardous way, having regard to the nature, density and site of application of the energy, the device is classified as Class IIb. (3) An active medical device that is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of an active medical device for therapy of the kind mentioned in subclause (2) is classified as Class IIb. (4) An active medical device for therapy that includes a diagnostic function the purpose of which is to significantly determine patient management by the device is classified as Class III. > Note: Example: An automated external defibrillator. #### 4.3 Active medical devices for diagnosis (1) This clause applies to an active medical device for diagnosis. (2) If: (a) the device is intended by the manufacturer to be used to supply energy that will be absorbed by a patient’s body (other than a device that is intended only to illuminate the patient’s body in the visible spectrum); or (b) the device is intended by the manufacturer to be used to image in vivo distribution of radiopharmaceuticals in a patient; or (c) the device is intended by the manufacturer to be used to allow direct diagnosis or monitoring of vital physiological processes of a patient (other than a device of a kind mentioned in paragraph (3)(a)); the device is classified as Class IIa. > Note for paragraph (a): A device that is intended only to illuminate the patient’s body in the visible spectrum is classified as Class I—see clause 4.1 of this Schedule. (3) If: (a) the device is intended by the manufacturer specifically to be used to monitor vital physiological parameters of a patient, and the nature of the variations monitored is of a kind that could result in immediate danger to the patient (for example, variations in cardiac performance, respiration, activity of the central nervous system); or (b) the device is intended by the manufacturer to emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology; or (c) the device is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of a device of the kind mentioned in paragraph (b); the device is classified as Class IIb. #### 4.4 Active medical devices intended to administer or remove medicines, etc from a patient’s body (1) Subject to subclause (2), an active medical device that is intended by the manufacturer to be used to administer medicine, body liquids or other substances to a patient, or to remove medicine, body liquids or other substances from a patient, is classified as Class IIa. (2) If the device is of a kind such that the administration or removal of the medicine, body liquids or other substances is potentially hazardous to the patient, having regard to the nature of the substances involved, the part of the patient’s body concerned, and the characteristics of the device, the device is classified as Class IIb. #### 4.5 Programmed or programmable medical device or software that is a medical device for use in relation to diagnosing or screening for a disease or condition (1) A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to: (a) provide a diagnosis of a disease or condition; or (b) screen for a disease or condition; is classified as: (c) in the case of a disease or condition that: (i) may lead to the death of a person, or a severe deterioration in the state of a person’s health, without urgent treatment; or (ii) may pose a high risk to public health; Class III; or (d) in the case of a serious disease or serious condition or a disease or condition that may pose a moderate risk to public health, and where paragraph (c) does not apply—Class IIb; or (e) in any other case—Class IIa. (2) A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to provide information to a relevant health professional for the purposes of the health professional making a diagnosis of a disease or condition: (a) in the case of a disease or condition that: (i) may lead to the death of a person, or a severe deterioration in the state of a person’s health, without urgent treatment; or (ii) may pose a high risk to public health; is classified as Class IIb; or (b) in the case of a serious disease or serious condition or a disease or condition that may pose a moderate risk to public health, and where paragraph (a) does not apply—is classified as Class IIa; or (c) in any other case—is classified as Class I. #### 4.6 Programmed or programmable medical device or software that is a medical device for use for monitoring the state or progression of a disease or condition etc. A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to provide information that is to be used for monitoring the state or progression of a disease or condition of a person or the parameters in relation to a person: (a) in the case where the information to be provided could indicate that the person or another person may be in immediate danger or that there may be a high risk to public health—is classified as Class IIb; or (b) in the case where the information to be provided could indicate that the person or another person may be in other danger or that there may be a moderate risk to public health—is classified as Class IIa; or (c) in any other case—is classified as Class I. #### 4.7 Programmed or programmable medical device or software that is a medical device for use in specifying or recommending treatment or intervention (1) Subject to subclause (2), a programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to specify or recommend a treatment or intervention: (a) in the case where the absence of the treatment or intervention or where the treatment or intervention itself: (i) may lead to the death of a person or a severe deterioration in the state of a person’s health; or (ii) may pose a high risk to public health; is classified as Class III; or (b) in the case where the absence of the treatment or intervention or where the treatment or intervention itself: (i) may otherwise be harmful to a person; or (ii) may pose a moderate risk to public health; is classified as Class IIb; or (c) in any other case—is classified as Class IIa. (2) A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to recommend a treatment or intervention (the recommended treatment or intervention) to a relevant health professional for the purposes of the health professional making a decision about the treatment or intervention: (a) in the case where the absence of the recommended treatment or intervention or where the recommended treatment or intervention itself: (i) may lead to the death of a person or a severe deterioration in the state of a person’s health; or (ii) may pose a high risk to public health; is classified as Class IIb; or (b) in the case where the absence of the recommended treatment or intervention or where the recommended treatment or intervention itself: (i) may otherwise be harmful to a person; or (ii) may pose a moderate risk to public health; is classified as Class IIa; or (c) in any other case—is classified as Class I. #### 4.8 Programmed or programmable medical device or software that is a medical device that is to provide therapy to a person through the provision of information A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to provide therapy to a person through the provision of information to the person: (a) in the case of therapy that may result in the death of the person or a severe deterioration in the state of the person’s health—is classified as Class III; or (b) in the case of therapy that may cause serious harm to the person and where paragraph (a) does not apply—is classified as Class IIb; or (c) in the case of therapy that may cause harm to the person and where neither paragraph (a) nor (b) applies—is classified as Class IIa; or (d) in any other case—is classified as Class I. ## Part 5—Special rules for particular kinds of medical devices #### 5.1 Medical devices incorporating a medicine (1) This clause applies to a medical device of any kind that incorporates, or is intended to incorporate, as an integral part, a substance that: (a) if used separately, would be a medicine; and (b) is liable to act on a patient’s body with action ancillary to that of the device. (2) The device is classified as Class III. (3) For the purposes of this clause, any stable derivative of human blood or human plasma is considered to be a medicine. #### 5.2 Medical devices intended for contraception or prevention of sexually transmitted diseases (1) Subject to subclause (2), a medical device that is intended by the manufacturer to be used for contraception, or the prevention of sexually transmitted diseases, is classified as Class IIb. (2) If the device is an implantable medical device or an invasive medical device that is intended for long‑term use, the device is classified as Class III. #### 5.3 Medical devices intended for disinfecting, cleaning, etc (1) A medical device that is intended by the manufacturer specifically to be used for disinfecting, cleaning, rinsing or hydrating contact lenses is classified as Class IIb. (2) A medical device that is intended by the manufacturer specifically to be used for disinfecting another medical device is classified as Class IIb. (3) This clause does not apply to a medical device that is intended by the manufacturer to be used only to clean another medical device (other than contact lenses) by means of physical action. > Note: A medical device of the kind described in subclause (3) is classified as Class I—see clause 2.1 of this Schedule. #### 5.4 Medical devices that record patient images or that are anatomical models etc. (1) If: (a) a medical device is intended by the manufacturer to be used to record patient images that are to be used for either or both of the following: (i) the diagnosis or monitoring of a disease, injury or disability; (ii) the investigation of the anatomy or of a physiological process; and (b) the images are to be acquired through a method that relies on energy outside the visible spectrum; the device is classified as Class IIa. (2) A medical device that is an anatomical model (whether physical or virtual) that is intended by the manufacturer to be used for either or both of the following: (a) the diagnosis or monitoring of a disease, injury or disability; (b) the investigation of the anatomy or of a physiological process; is classified as Class IIa. (3) A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to generate a virtual anatomical model that is to be used for either or both of the following: (a) the diagnosis or monitoring of a disease, injury or disability; (b) the investigation of the anatomy or of a physiological process; is classified as Class IIa. #### 5.5 Medical devices containing non‑viable animal tissues, cells or their derivatives (1) Subject to subclause (2), this clause applies to a medical device if the device contains any of the following: (a) non‑viable tissues, or cells, of animal origin (other than tissues or cells from hair or wool); (b) derivatives of tissues or cells covered by paragraph (a) (other than sintered hydroxyapatite or tallow derivatives). (2) This clause does not apply to a medical device if the device is intended by the manufacturer to come into contact with intact skin only. (3) A device to which this clause applies is classified as Class III. #### 5.6 Medical devices that are blood bags A medical device that is a blood bag is classified as Class IIb. #### 5.7 Active implantable medical devices (1) An active implantable medical device is classified as Class III. (2) An implantable accessory to an active implantable medical device is classified as Class III. (3) An active medical device that is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of an active implantable medical device is classified as Class III. #### 5.8 Medical devices intended for export only Despite any other classification in this Schedule, a medical device that is intended by the manufacturer to be for export only is classified as Class I. #### 5.9 Medical devices that are mammary implants A medical device that is a mammary implant is classified as Class III. #### 5.10 Medical devices that administer medicines or biologicals by inhalation If a medical device is intended to be used to administer medicines or biologicals by inhalation: (a) if the mode of action of the device has an essential impact on the efficacy and safety of the medicines or biologicals—the device is classified as Class IIb; or (b) if the device is intended to treat a life‑threatening condition—the device is classified as Class IIb; or (c) if paragraphs (a) and (b) do not apply—the device is classified as Class IIa. #### 5.11 Medical devices that are substances to be introduced into the body or applied to and absorbed by the skin If a medical device is composed of substances, or combinations of substances, that are intended to be: (a) introduced into the human body through a body orifice; or (b) applied to and absorbed by the skin; the device is classified as follows: (c) if the device is introduced into the nasal or oral cavity as far as the pharynx, or is applied to and absorbed by the skin, and achieves its intended purpose in that cavity or on the skin—Class IIa; (d) in any other case—Class IIb. Schedule 2A—Classification rules for IVD medical devices Note: Regulation 3.2 provides for the making of classification rules. Regulation 3.3 sets out the principles for applying those rules. #### 1.1 Detection of transmissible agents posing high public health risk An IVD medical device intended to be used for any of the following purposes is classified as a Class 4 IVD medical device or a Class 4 in‑house IVD medical device: (a) to detect the presence of, or exposure to, transmissible agents in blood, blood components, blood products, cells, tissues or organs or any derivatives of these products of human or animal origin, in order to assess their suitability for transfusion or transplantation; (b) to detect the presence of, or exposure to, a transmissible agent that causes a serious disease with a high risk of propagation in Australia. #### 1.2 Detection of red blood cell antigens and antibodies and non‑red cell typing (1) An IVD medical device is classified as a Class 3 IVD medical device or a Class 3 in‑house IVD medical device if: (a) the device is intended to be used for detection of biological markers in order to assess the immunological compatibility of blood, blood components, blood products, cells, tissues or organs that are intended for transfusion or transplantation; and (b) the device is not a device mentioned in subclause (2). (2) An IVD medical device intended to detect any of the following markers mentioned for the following blood group systems is classified as a Class 4 IVD medical device or a Class 4 in‑house IVD medical device: (a) ABO system—ABO1 (A), ABO2 (B), ABO3 (AB); (b) Rhesus system—RH1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e); (c) Kell system—KEL1 (K); (d) Kidd system—JK1 (Jka), JK2 (Jkb); (e) Duffy system—FY1 (Fya), FY2 (Fyb). #### 1.3 Detection of transmissible agents or biological characteristics posing moderate public health risk or high personal risk An IVD medical device is classified as a Class 3 IVD medical device or a Class 3 in‑house IVD medical device if it is intended for any of the following uses: (a) detecting the presence of, or exposure to, a sexually transmitted agent; (b) detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation; (c) detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual or foetus being tested; (d) pre‑natal screening of women in order to determine their immune status towards transmissible agents; (e) determining infective disease status or immune status, if there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life‑threatening situation for the patient; (f) the selection of patients: (i) for selective therapy and management; or (ii) for disease staging; or (iii) in the diagnosis of cancer; (fa) use as an IVD companion diagnostic; (g) human genetic testing; (h) to monitor levels of medicines, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in an immediate life‑threatening situation for the patient; (i) the management of patients suffering from a life‑threatening infectious disease; (j) screening for congenital disorders in a foetus. > Note for paragraph (f): An IVD medical device (except an IVD companion diagnostic) would fall into Class 2 under clause 1.7 if: (a) a therapy decision would usually be made only after further investigation; or (b) the device is used for monitoring. #### 1.4 IVD medical devices for self‑testing An IVD medical device for self‑testing is classified as a Class 3 IVD medical device unless: (a) the result of the examination is not determining a serious condition, ailment or defect; or (b) the examination is preliminary and follow‑up additional testing is required. #### 1.5 Non assay‑specific quality control material Despite clauses 1.1 to 1.4, an IVD medical device that is intended to be used as non assay‑specific quality control material is classified as a Class 2 IVD medical device or a Class 2 in‑house IVD medical device. #### 1.6 Reagents, instruments etc (1) A reagent or other article that possesses specific characteristics, intended by the manufacturer, to make it suitable for in vitro diagnostic procedures related to a specific examination is classified as a Class 1 IVD medical device or a Class 1 in‑house IVD medical device. (2) Despite clauses 1.1 to 1.5, the following IVD medical devices are classified as Class 1 IVD medical devices or Class 1 in‑house IVD medical devices: (a) an instrument, intended by the manufacturer, to be specifically used for in vitro diagnostic procedures; (b) a specimen receptacle, other than a specimen receptacle that is intended for use in self‑testing; (c) a microbiological culture medium. (3) In this clause: > examination means a set of operations having the object of determining the value or characteristics of a property. > Note: In some disciplines (for example, microbiology) an examination is the combination of a number of tests, observations or measurements. > specimen receptacle means a device, whether vacuum‑type or not, specifically intended by its manufacturer for the primary containment and preservation of a specimen derived from the human body for the purpose of in vitro diagnostic examination. > Note 1: A specimen receptacle is considered to be an IVD medical device. > Note 2: A product for general laboratory use is not an IVD medical device unless the product is specifically intended by its manufacturer to be used for in vitro diagnostic examination. #### 1.7 Other IVD medical devices are Class 2 IVD medical devices An IVD medical device not mentioned in this Schedule is classified as a Class 2 IVD medical device or a Class 2 in‑house IVD medical device. #### 1.8 IVD medical devices intended for export only Despite clauses 1.1 to 1.7, an IVD medical device is classified as a Class 1 IVD medical device if it is intended by the manufacturer for export only. Schedule 3—Conformity assessment procedures (regulation 3.4) ## Part 1—Full quality assurance procedures #### 1.1 Overview The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device: (a) to: (i) implement a quality management system for the design, production, packaging, labelling and final inspection of the kind of device; and (ii) arrange for assessment of the system by the Secretary or an Australian conformity assessment body; and (b) for a Class 4 IVD medical device, Class 4 in‑house IVD medical device or Class III medical device—to arrange for examination of the design of the kind of device by the Secretary or an Australian conformity assessment body; and (c) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out inspections of, the system; and (d) to make a declaration of conformity in relation to the kind of device; and (e) to: (i) notify the Secretary or an Australian conformity assessment body of any change to the system, or to the kinds of devices to which the system is to be applied; and (ii) arrange for assessment of any such change by the Secretary or an Australian conformity assessment body; and (f) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system. > Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied. #### 1.2 References to kinds of medical devices A reference in this Part to a kind of medical device includes a reference to an individual medical device. #### 1.3 Implementation and assessment of quality management system (1) The manufacturer of a kind of medical device must: (a) implement a quality management system for the design, production, packaging, labelling and final inspection of the kind of device; and (b) arrange for assessment of the system by the Secretary or an Australian conformity assessment body. (2) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings: (a) the name and business address of the manufacturer; (b) details of each manufacturing site where the system is to be applied; (c) all relevant information about the kind of medical devices to which the system is to be applied; (d) the documentation in relation to the system; (e) an undertaking by the manufacturer to continue to comply with the requirements of the system after assessment; (f) an undertaking by the manufacturer to ensure that the system is at all times adequate and efficacious; (g) an undertaking by the manufacturer: (i) if the manufacturer arranged for assessment of the system by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 1.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or (ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 1.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device. #### 1.4 Requirements of quality management system (1) A quality management system that is to be assessed under clause 1.3 must meet the requirements of this clause. (2) The system must be of a kind such that its application will ensure that each medical device to which the system is applied complies with the applicable provisions of the essential principles, the classification rules, and these conformity assessment procedures, at each stage, from the design of the device until its final inspection before being supplied. (3) The system must include post‑marketing requirements under which the manufacturer of a medical device to which the system is applied is required: (a) to systematically review experience gained, post‑production, in relation to medical devices of that kind; and (b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and (c) to: (i) if the manufacturer arranged for assessment of the system under clause 1.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or (ii) if the manufacturer arranged for assessment of the system under clause 1.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A). > Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary. (3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following: (a) information relating to: (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or (ii) any inadequacy in the design, production, labelling or instructions for use of the kind of device, or in the advertising material for the kind of device; or (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device; that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health; (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed. (4) Each requirement of the system must be documented in a systematic and orderly way in the form of written policies and procedures (for example, as quality programs, quality plans, quality manuals or quality records). (5) The documentation of the system must include adequate information in relation to the following matters: (a) the manufacturer’s quality objectives; (b) the organisation of the manufacturer’s business, including, in particular, a description of the following: (i) the organisational structure of the business; (ii) the responsibilities of managerial staff and their authority in relation to the quality of the design and production of medical devices manufactured by the manufacturer; (iii) the methods of monitoring whether the system is operating effectively, in particular, whether the desired quality of design and product is being achieved and how products that fail to meet the desired quality are controlled; (c) the design of the kind of medical device to which the system is to be applied, including, in particular, the following: (i) details of the processes, systems and measures used for controlling, monitoring and verifying that at each stage of the design process, the device complies with the applicable provisions of the essential principles; (ii) a general description of the kind of device, and of any variants of the kind of device, that the manufacturer plans to manufacture; (iii) details of the design specifications for the kind of device, including: (A) any medical device standard or conformity assessment standard that has been applied to the device; and (B) the results of the risk analysis carried out; and (C) if no medical device standard or conformity assessment standard, or part only of such a standard, has been applied to the device—the solutions adopted to ensure that each device complies with the applicable provisions of the essential principles; (iv) for a kind of device that is intended by the manufacturer to be connected to another device—evidence demonstrating that the device will comply with the applicable provisions of the essential principles when it is connected to the other device and both devices are being used for their intended purposes; (v) a statement indicating whether or not the kind of device incorporates, or is intended to incorporate, as an integral part, a substance mentioned in clause 7.4 of the essential principles, and, for a device that will do so, data derived from tests conducted in relation to the device and the substance, and their interaction; (vi) a statement indicating whether or not the device, other than an IVD medical device, contains tissues, cells or substances of animal origin that have been rendered non‑viable, or tissues, cells or substances of microbial or recombinant origin; (via) for an IVD medical device—a statement indicating whether or not the device contains viable tissues, cells, or substances of human or animal origin; (vii) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures; (viii) a copy of the information to be provided with the kind of device; (d) the inspection and quality assurance techniques to be applied in the production of the kind of medical device to which the system is to be applied, including, in particular, information about the following: (i) the processes and procedures to be used (particularly in relation to sterilisation) and the documents relating to those processes and procedures; (ii) the procedures to be used for purchasing goods or services in relation to the production of the kind of device and the documents relating to those procedures; (iii) product identification procedures to be prepared and kept up‑to‑date from drawings, specifications or other documents at each stage of production; (e) the tests or trials to be carried out before, during and after production of the kind of medical device to which the system is to be applied, including, in particular, information about: (i) the frequency with which the tests or trials are to be carried out; and (ii) the equipment (including the traceability of the calibration of the equipment) used, or to be used, to carry out the tests or trials; (f) the system for reviewing experience gained in the post‑production phase in relation to the kind of medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied in relation to the design or production of such devices; (g) whether a conformity assessment standard has been applied to the system and, if no conformity assessment standard, or part only of a conformity assessment standard, has been applied to the system—the solutions adopted to ensure that the system complies with subclause (2). #### 1.5 Changes to quality management system or kinds of medical device to which system is to be applied (1) This clause applies to the manufacturer of a kind of medical device if: (a) the manufacturer has implemented, and had assessed under clause 1.3 of this Schedule, a quality management system that is to be applied to the kind of device; and (b) after assessment, the manufacturer plans to make: (i) a substantial change to the system; or (ii) a change to the kinds of medical devices to which the system is to be applied. (2) The manufacturer must: (a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and (b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 1.4 of this Schedule. (3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 1.3(2) of this Schedule in relation to the system or kinds of devices. (4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 1.4 of this Schedule. #### 1.6 Examination of design of Class 4 IVD medical device, Class 4 in‑house IVD medical device or Class III medical device (1) This clause applies to the manufacturer of a Class 4 IVD medical device, a Class 4 in‑house IVD medical device or a Class III medical device, to which the quality management system that is to be assessed under clause 1.3 is to be applied. (2) For the purpose of assessing whether the kind of medical device complies with the applicable provisions of the essential principles, the manufacturer of the device must arrange for examination by the Secretary or an Australian conformity assessment body of the design of the kind of device. (3) For the purpose of enabling the examination to be carried out, the manufacturer must have available: (a) information, in writing, in relation to the following matters in relation to the kind of medical device: (i) the design; (ii) the production process; (iii) the intended performance; and (b) a copy of the documentation mentioned in paragraph 1.4(5)(c) of this Schedule necessary to assess whether the kind of medical device complies with the applicable provisions of the essential principles. (4) If, after examination by the Secretary or an Australian conformity assessment body of the design of a kind of medical device, the manufacturer makes a substantial change to the design, or the intended performance, of the kind of device, the manufacturer must: (a) notify the Secretary or an Australian conformity assessment body, in writing, of the change; and (b) arrange for examination of the change by the Secretary or the Australian conformity assessment body to assess whether the design, or the intended performance, of the medical device, as changed, complies with the applicable provisions of the essential principles. (5) For the purpose of enabling an examination to be carried out under subclause (4), the manufacturer must have available, in writing, details of any consequential changes to the documentation in relation to the design of the device mentioned in paragraph 1.4(5)(c) of this Schedule. > Note: This clause need not be applied to: (a) a Class IIb medical device—see Division 3.2, paragraphs 3.7(1)(a) and (2)(a); or (b) a Class 3 IVD medical device—see Division 3.2, paragraph 3.7A(a); or (c) a Class IIa medical device—see Division 3.2, paragraphs 3.8(1)(a) and (2)(a); or (d) a Class 2 IVD medical device—see Division 3.2, paragraph 3.8A(a). #### 1.7 Information to be given to authorised person (1) If requested to do so by an authorised person, the manufacturer of a kind of medical device must: (a) give to the Secretary the following information in relation to the quality management system or the kinds of medical device to which the system is applied: (i) a copy of the documentation mentioned in subclause 1.4(5) of this Schedule; (ii) data in relation to the design of the kinds of medical device (for example, the results of any analysis of the device, calculations, tests); (iii) data in relation to the manufacture of the kinds of medical device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and (b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively. (2) If any inspections or tests are carried out by an authorised person in relation to the manufacturer’s premises, or medical devices produced by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests. #### 1.8 Declaration of conformity (1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 1.3 of this Schedule has been applied must make a declaration of conformity in relation to the kind of device. (2) The declaration must: (a) state that the declaration is a declaration of conformity made under clause 1.8 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and (b) state the name and business address of the manufacturer of the device; and (c) state the following information in relation to each kind of medical device to which the system has been applied: (i) the unique product identifier; (ii) the medical device classification; (iii) the device nomenclature system code; and (d) if the system has not been applied to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the system has been applied (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and (e) state that each kind of medical device to which the system has been applied complies with the applicable provisions of the essential principles, the classification rules, and the full quality assurance procedures, at each stage, from the design of the device until its final inspection before being supplied; and (f) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and (g) give details of any conformity assessment standard or medical device standard that has been applied to a kind of device to which the system has been applied; and (h) be signed by a person authorised by the manufacturer; and (i) set out the name and position of the person signing the declaration; and (j) state the date when the declaration is signed. #### 1.9 Records (1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 1.3 of this Schedule has been applied must keep the following records in relation to the system and the kind of device: (a) the documentation mentioned in subclause 1.4(5) of this Schedule; (b) details of any changes made to the system and to the information and documentation required under subclause 1.3(2) of this Schedule; (c) if the device is a Class 4 IVD medical device, Class 4 in‑house IVD medical device or Class III medical device, the information and documentation required under subclause 1.6(3) of this Schedule; (d) details of any changes made to the kind of medical device and to the documentation in relation to the design of the device mentioned in paragraph 1.4(5)(c) of this Schedule; (e) the declaration of conformity under clause 1.8 of this Schedule; (f) details of the systematic review carried out, post‑production, in relation to medical devices of that kind; (g) any notice, report, certificate or other document in relation to the system issued to the manufacturer by the Secretary or an Australian conformity assessment body. (2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the quality management system was applied. (3) On request from the Secretary, the manufacturer must make the records available to the Secretary. ## Part 2—Type examination procedures #### 2.1 Overview The conformity assessment procedures set out in this Part provide for the manufacturer to arrange for examination by the Secretary or an Australian conformity assessment body of a representative sample of a kind of medical device (the type). > Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied. #### 2.2 References to kinds of medical devices A reference in this Part to a kind of medical device includes a reference to an individual medical device. #### 2.3 Examination of type (1) The manufacturer of a medical device must arrange for examination of the type by the Secretary or an Australian conformity assessment body. (2) For the purpose of enabling the examination to be carried out, the manufacturer must have available, in writing, the following information: (a) the name and business address of the manufacturer; (b) the documentation mentioned in subclause (3) in relation to the type. (3) For paragraph (2)(b), the documentation must include adequate information about the design, production process and intended performance of the type, and must include, in particular, the following: (a) a general description of the type, and of any variants of the type that the manufacturer plans to manufacture; (b) diagrams or drawings of the design of the type, including diagrams or drawings of any components, sub‑assemblies or circuits of the type; (c) any descriptions or explanations that are necessary to enable the diagrams or drawings mentioned in paragraph (b), or the intended operation of the type, to be properly understood; (d) the proposed method or methods of manufacture of the type; (e) if the type is intended by the manufacturer to be supplied in a sterile state—a description of the method used to sterilise the type; (f) details of each medical device standard or conformity assessment standard that has been applied, wholly or in part, to the type; (g) if no medical device standard or conformity assessment standard has been applied, or such a standard has been only partly applied, to the type—descriptions of the solutions adopted to ensure that the type complies with the applicable provisions of the essential principles; (h) the results of any design calculations, risk analyses, investigations, technical tests, or any other tests, carried out in relation to the type; (i) a statement indicating whether or not the type incorporates, or is intended to incorporate, as an integral part, a substance mentioned in clause 7.4 of the essential principles, and, for a type that does so, data derived from tests conducted in relation to the type and the substance, and their interaction; (j) a statement indicating whether or not the device, other than an IVD medical device, contains tissues, cells or substances of animal origin that have been rendered non‑viable, or tissues, cells or substances of microbial or recombinant origin; (ja) for an IVD medical device—a statement indicating whether or not the device contains viable tissues, cells, or substances of human or animal origin; (k) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures; (l) a copy of the information to be provided with the type. (4) The manufacturer must make available to the Secretary or the Australian conformity assessment body for examination: (a) a sample of the type; and (b) on request from the Secretary or the Australian conformity assessment body, additional samples of the type. (5) If the type is intended by the manufacturer to be connected to another medical device, the manufacturer must, on request from the Secretary or the Australian conformity assessment body, make available to the Secretary or the Australian conformity assessment body, or arrange for the Secretary or the Australian conformity assessment body to have access to, a sample of the device. #### 2.4 Changes to design of medical device after examination (1) This clause applies if, after examination by the Secretary or an Australian conformity assessment body of a type, the manufacturer of the type plans to make a substantial change to the design, or intended performance, of the kind of medical device to which the type relates. (2) The manufacturer must: (a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and (b) arrange for examination of the change by the Secretary or the Australian conformity assessment body to verify whether the type, as changed, meets the requirements of clause 2.3 of this Schedule. (3) For the purpose of enabling the examination to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the documentation required under subclause 2.3(3) of this Schedule in relation to the type. #### 2.5 Records (1) The manufacturer of the type that has been examined under this Part must keep the following records: (a) the documentation required under subclause 2.3(3) of this Schedule in relation to the type; (b) details of any changes made to the type and to the documentation required under subclause 2.3(3) of this Schedule; (c) any notice, report, certificate or other document in relation to the type issued to the manufacturer by the Secretary or an Australian conformity assessment body. (2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device of that type. (3) On request from the Secretary, the manufacturer must make the records available to the Secretary. ## Part 3—Verification procedures #### 3.1 Overview The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device: (a) to arrange for examination and testing of the kind of device by the Secretary or an Australian conformity assessment body; and (b) to make a declaration of conformity in relation to the kind of device; and (c) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system. > Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied. #### 3.2 References to kinds of medical devices A reference in this Part to a kind of medical device includes a reference to an individual medical device. #### 3.3 Verification of conformity (1) The manufacturer of a medical device must arrange for examination and testing by the Secretary or an Australian conformity assessment body of each device of that kind, or a representative sample from a batch of medical devices of that kind, to verify that: (a) for a kind of device in relation to which the type examination procedures have been applied—each device, or representative sample, conforms to the approved type; and (b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—each device, or representative sample, is in accordance with the technical documentation prepared under clause 6.4 of those procedures for that kind of device; and (c) each device, or representative sample, complies with the applicable provisions of the essential principles, the classification rules and these conformity assessment procedures. (2) For the purpose of enabling the examination and testing to be carried out, the manufacturer must have available, in writing, the following information and undertakings: (a) the name and business address of the manufacturer; (b) the documentation describing the manufacturing process to be used to manufacture the kind of device; (c) a description of the procedures that have been, or will be, implemented to ensure that all devices of that kind manufactured by the manufacturer will be uniform; (d) an undertaking to implement those procedures to ensure that all devices of that kind manufactured by the manufacturer will be uniform; (e) an undertaking by the manufacturer: (i) if the manufacturer arranged for examination and testing by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 3.4(2A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or (ii) if the manufacturer arranged for examination and testing by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 3.4(2A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; (f) for a kind of device in relation to which the type examination procedures have been applied—evidence that the device conforms to the approved type and a copy of the technical documentation required under subclause 2.3(3) of the type examination procedures for the approved type; (g) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—a copy of the technical documentation prepared under clause 6.4 of those procedures for that kind of device. (3) The manufacturer must make available to the Secretary or the Australian conformity assessment body for examination and testing: (a) for a kind of device in relation to which the type examination procedures have been applied: (i) each medical device that is to be verified in relation to the approved type; or (ii) each medical device selected by the Secretary or the Australian conformity assessment body on a statistical basis from a uniform batch of devices that are to be verified in relation to the approved type; and (b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied: (i) each medical device of that kind to which those procedures have been applied; or (ii) each medical device selected by the Secretary or the Australian conformity assessment body on a statistical basis from a uniform batch of devices of that kind to which those procedures have been applied. #### 3.4 Requirements of manufacturing system (1) The manufacturer of a medical device must ensure that: (a) for a kind of device in relation to which the type examination procedures have been applied—the process used to manufacture the device results in the device conforming to the approved type; and (b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—the process used to manufacture the device results in the device being in accordance with the technical documentation prepared under clause 6.4 of those procedures for that kind of device. (2) The manufacturer of a medical device of a kind mentioned in subclause (1) must ensure that the process used to manufacture the device includes post‑marketing requirements under which the manufacturer is required: (a) to systematically review experience gained in the post‑production phase in relation to medical devices of that kind; and (b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and (c) to: (i) if the manufacturer arranged for examination and testing under clause 3.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (2A); or (ii) if the manufacturer arranged for examination and testing under clause 3.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (2A). > Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary. (2A) For the purposes of subparagraphs (2)(c)(i) and (ii), the information is the following: (a) information relating to: (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device; that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health; (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed. (3) Before manufacturing a medical device of a kind mentioned in subclause (1), the manufacturer must prepare documentation describing the manufacturing process to be used to produce the device. (4) Without limiting subclause (3), the documentation must include a description of the procedures that have been, or will be, implemented to ensure that all devices of that kind manufactured by the manufacturer will be uniform. #### 3.5 Declaration of conformity (1) The manufacturer of a Class III medical device or Class IIb medical device that has been verified under this Part must make a declaration of conformity in relation to the kind of device. > Note: This clause need not be applied to the following kinds of medical devices if the declaration of conformity (not requiring assessment by Secretary) procedures have been applied to the device: (a) a Class IIa medical device (see Division 3.2, subparagraph 3.8(1)(b)(i)); (b) a Class I medical device that has a measuring function (see Division 3.2, paragraph 3.9(3)(a)). (2) The declaration must: (a) state that the declaration is a declaration of conformity made under clause 3.5 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and (b) state the name and business address of the manufacturer of the device; and (c) state the following information in relation to each device that has been verified: (i) the unique product identifier; (ii) the medical device classification; (iii) the device nomenclature system code; and (d) if the verification does not relate to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the verification relates (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and (e) for a kind of device in relation to which the type examination procedures have been applied: (i) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the approved type; and (ii) state that the kind of device conforms to the approved type; and (f) state that each kind of medical device or batch of devices complies with the applicable provisions of the essential principles and the classification rules; (g) state the basis on which the declaration is made; and (h) give details of any conformity assessment standard or medical device standard that has been applied to the kind of device or the processes used to manufacture the device; and (i) be signed by a person authorised by the manufacturer; and (j) set out the name and position of the person signing the declaration; and (k) state the date when the declaration is signed. #### 3.6 Records (1) The manufacturer of a kind of medical device that has been verified under this Part must keep the following records: (a) the documentation mentioned in subclause 3.4(3) of this Schedule; (b) for a Class III medical device or Class IIb medical device—the declaration of conformity under clause 3.5 of this Schedule; (c) any notice, report, certificate or other document in relation to the device, or a batch of devices that includes the device, issued to the manufacturer by the Secretary or an Australian conformity assessment body. (2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the verification relates. (3) On request from the Secretary, the manufacturer must make the records available to the Secretary. ## Part 4—Production quality assurance procedures #### 4.1 Overview The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device: (a) to: (i) implement a quality management system for the production and final inspection of the kind of device; and (ii) arrange for assessment of the system by the Secretary or an Australian conformity assessment body; and (b) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out inspections of, the system; and (c) to make a declaration of conformity in relation to the kind of device; and (d) to: (i) notify the Secretary or an Australian conformity assessment body of any change to the system; and (ii) arrange for assessment of any such change by the Secretary or an Australian conformity assessment body; and (e) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system. > Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied. #### 4.2 References to kinds of medical devices A reference in this Part to a kind of medical device includes a reference to an individual medical device. #### 4.3 Implementation and assessment of production quality management system (1) The manufacturer of a medical device must: (a) implement a quality management system for the production and final inspection of the kind of device; and (b) arrange for assessment of the system by the Secretary or an Australian conformity assessment body. (2) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings: (a) the name and business address of the manufacturer; (b) details of each manufacturing site where the system is to be applied; (c) all relevant information about the kinds of medical devices to which the system is to be applied; (d) the documentation in relation to the system; (e) an undertaking by the manufacturer to continue to comply with the requirements of the system after assessment; (f) an undertaking by the manufacturer to ensure that the system is at all times adequate and efficacious; (g) for a kind of device in relation to which the type examination procedures have been applied—evidence that the device conforms to the approved type and a copy of the technical documentation required under subclause 2.3(3) of the type examination procedures for the approved type; (h) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—a copy of the technical documentation prepared under clause 6.4 of those procedures for that kind of device; (i) an undertaking by the manufacturer: (i) if the manufacturer arranged for assessment of the system by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 4.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or (ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 4.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device. #### 4.4 Requirements of production quality management system (1) A quality management system that is to be assessed under clause 4.3 must meet the requirements of this clause. (2) The system must be of a kind such that its application will ensure that: (a) each medical device to which the system is applied that is of a kind in relation to which the type examination procedures have been applied conforms to the approved type; and (b) each medical device to which the system is applied that is of a kind to which the declaration of conformity (not requiring assessment by Secretary) procedures are applied is in accordance with the technical documentation prepared under clause 6.4 of those procedures for the device. (3) The system must include post‑marketing requirements under which the manufacturer of a medical device to which the system is applied is required: (a) to systematically review experience gained in the post‑production phase in relation to medical devices of that kind; and (b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and (c) to: (i) if the manufacturer arranged for assessment of the system under clause 4.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or (ii) if the manufacturer arranged for assessment of the system under clause 4.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A). > Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary. (3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following: (a) information relating to: (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device; that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health; (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed. (4) Each requirement of the system must be documented in a systematic and orderly way in the form of written policies and procedures (for example, as quality programs, quality plans, quality manuals or quality records). (5) The documentation of the system must include adequate information in relation to the following matters: (a) the manufacturer’s quality objectives; (b) the organisation of the manufacturer’s business, including, in particular, a description of the following: (i) the organisational structure of the business; (ii) the responsibilities of managerial staff and their authority in relation to the production of the medical devices produced by the manufacturer; (iii) the methods of monitoring whether the system is operating effectively, in particular, whether the desired quality of product is being achieved and how products that fail to meet the desired quality are controlled; (c) the inspection and quality assurance techniques applied in the manufacturing process, including, in particular, information about the following: (i) the processes and procedures to be used (particularly in relation to sterilisation) and the documents relating to those procedures; (ii) the procedures to be used for purchasing goods or services in relation to the production of the kind of device produced and the documents relating to those procedures; (iii) product identification procedures to be prepared and kept up‑to‑date from drawings, specifications or other documents at each stage of manufacture; (d) the tests or trials to be carried out before, during and after production of the kind of medical device to which the system is to be applied, including, in particular, information about: (i) the frequency with which the tests or trials are to be carried out; and (ii) the equipment (including the traceability of the calibration of the equipment) used, or to be used, to carry out the tests or trials; (e) the system for reviewing experience gained in the post‑production phase in relation to the kind of medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied in relation to the design or production of such devices; (f) whether a conformity assessment standard has been applied to the system and, if no conformity assessment standard, or part only of a conformity assessment standard, has been applied to the system—the solutions adopted to ensure that the system complies with subclause (2). #### 4.5 Changes to production quality management system (1) This clause applies to the manufacturer of a medical device if: (a) the manufacturer has implemented, and had assessed under clause 4.3 of this Schedule, a quality management system that is to be applied to the device; and (b) after assessment, the manufacturer plans to make a substantial change to the system. (2) The manufacturer must: (a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and (b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 4.4 of this Schedule. (3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 4.3(2) of this Schedule in relation to the system. (4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 4.4 of this Schedule. #### 4.6 Information to be given to authorised person (1) If requested to do so by an authorised person, the manufacturer of a medical device must: (a) give to the Secretary the following information in relation to the quality management system or the kinds of medical device to which the system is applied: (i) a copy of the documentation mentioned in subclause 4.4(5) of this Schedule; (ii) data in relation to the production of the kinds of medical device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and (b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively. (2) If any inspections or tests are carried out by an authorised person under this clause, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests. #### 4.7 Declaration of conformity (1) The manufacturer of a Class 4 IVD medical device, Class 3 IVD medical device, Class III medical device or Class IIb medical device to which a quality management system that has been assessed under clause 4.3 of this Schedule has been applied must make a declaration of conformity in relation to the kind of device. > Note: This clause need not be applied to the following kinds of medical devices, if the declaration of conformity (not requiring assessment by Secretary) procedures have been applied to the device: (a) a Class IIa medical device—see Division 3.2, subparagraph 3.8(1)(b)(ii); (b) a Class 2 IVD medical device—see Division 3.2, paragraph 3.8A(b); (c) a Class I medical device that the manufacturer intends to be supplied in a sterile state—see Division 3.2, subclause 3.9(2); (d) a Class I medical device that has a measuring function—see Division 3.2, paragraph 3.9(3)(b). (2) The declaration must: (a) state that the declaration is a declaration of conformity made under clause 4.7 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and (b) state the name and business address of the manufacturer of the device; and (c) state the following information in relation to each kind of medical device to which the system has been applied: (i) the medical device classification; (ii) the device nomenclature system code; and (d) if the system has not been applied to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the system has been applied (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and (e) for a kind of device in relation to which the type examination procedures have been applied—state that: (i) the type examination procedures have been applied to the kind of device; and (ii) the kind of device conforms to the approved type; and (f) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and (g) state that each kind of medical device to which the system has been applied complies with the applicable provisions of the essential principles, the classification rules and the production quality assurance procedures before being supplied; and (h) give details of any conformity assessment standard that has been applied to the system; and (i) be signed by a person authorised by the manufacturer; and (j) set out the name and position of the person signing the declaration; and (k) state the date when the declaration is signed. #### 4.8 Records (1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 4.3 of this Schedule has been applied must keep the following records in relation to the system and the kind of device: (a) the documentation mentioned in subclause 4.4(5) of this Schedule; (b) details of any changes made to the system and to the information and documentation required under subclause 4.5(3) of this Schedule; (c) for a Class 4 IVD medical device, Class 3 IVD medical device, Class III medical device or Class IIb medical device—the declaration of conformity under clause 4.7 of this Schedule; (d) any notice, report, certificate or other document in relation to the system issued to the manufacturer by the Secretary or an Australian conformity assessment body. (2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the quality management system was applied. (3) On request from the Secretary, the manufacturer must make the records available to the Secretary. ## Part 5—Product quality assurance procedures #### 5.1 Overview The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device: (a) to: (i) implement a product quality management system for the final inspection and testing of the kind of device; and (ii) arrange for assessment of the system by the Secretary or an Australian conformity assessment body; and (b) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out inspections of, the system; and (c) to make a declaration of conformity in relation to the kind of device; and (d) to: (i) notify the Secretary or an Australian conformity assessment body of any change to the system, or to the kinds of devices to which the system is to be applied; and (ii) arrange for assessment of any such change by the Secretary or an Australian conformity assessment body; and (e) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system. > Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied. #### 5.2 References to kinds of medical devices A reference in this Part to a kind of medical device includes a reference to an individual medical device. #### 5.3 Implementation and assessment of product quality management system (1) The manufacturer of a medical device must: (a) implement a product quality management system for the final inspection and testing of the kind of device; and (b) arrange for assessment of the system by the Secretary or an Australian conformity assessment body. (2) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings: (a) the name and business address of the manufacturer; (b) details of each manufacturing site where the system is to be applied; (c) all relevant information about the kinds of medical devices to which the system is to be applied; (d) the documentation in relation to the system; (e) an undertaking by the manufacturer to continue to comply with the requirements of the system after assessment; (f) an undertaking by the manufacturer to ensure that the system is at all times adequate and efficacious; (g) for a kind of device in relation to which the type examination procedures have been applied—evidence that the device conforms to the approved type and the technical documentation required under subclause 2.3(3) of the type examination procedures for the device; (h) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—a copy of the technical documentation prepared under clause 6.4 of those procedures for that kind of device; (i) an undertaking by the manufacturer: (i) if the manufacturer arranged for assessment of the system by the Secretary—to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 5.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device; or (ii) if the manufacturer arranged for assessment of the system by an Australian conformity assessment body—to notify the body, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in paragraph 5.4(3A)(a) or (b) that the manufacturer becomes aware of in relation to the kind of medical device. #### 5.4 Requirements of product quality management system (1) A quality management system that is to be assessed under clause 5.3 must meet the requirements of this clause. (2) The system must be of a kind such that its application will ensure that each medical device, or representative sample of each batch of medical devices, is examined and tested to ensure that the device, or representative sample: (a) for a kind of device in relation to which the type examination procedures have been applied—conforms to the approved type; or (b) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—is in accordance with the technical documentation prepared under clause 6.4 of those procedures for the device. (3) The system must include post‑marketing requirements under which the manufacturer of a medical device to which the system is applied is required: (a) to systematically review experience gained in the post‑production phase in relation to medical devices of that kind; and (b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and (c) to: (i) if the manufacturer arranged for assessment of the system under clause 5.3 by the Secretary—notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A); or (ii) if the manufacturer arranged for assessment of the system under clause 5.3 by an Australian conformity assessment body—notify the body, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of information referred to in subclause (3A). > Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary. (3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following: (a) information relating to: (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device; that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health; (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed. (4) Each requirement of the system must be documented in a systematic and orderly way in the form of written policies and procedures (for example, as quality programs, quality plans, quality manuals or quality records). (5) The documentation of the system must include adequate information in relation to the following matters: (a) the manufacturer’s quality objectives; (b) the organisation of the manufacturer’s business, including, in particular, a description of the following: (i) the organisational structure of the business; (ii) the responsibilities of managerial staff and their authority in relation to the quality of the medical devices manufactured by the manufacturer; (iii) the methods of monitoring whether the system is operating effectively, in particular, whether the desired quality of product is being achieved and how products that fail to meet the desired quality are controlled; (c) the examinations and tests to be carried out after manufacture, including, in particular, information about: (i) the frequency with which the examinations and tests are to be carried out; and (ii) the equipment (including the traceability of the calibration of the equipment) to be used to carry out the examinations and tests; (d) the quality records to be kept, including, for example, records in relation to inspections, tests, calibration of equipment and qualifications of staff. #### 5.5 Changes to product quality management system or kinds of medical device (1) This clause applies to the manufacturer of a medical device if: (a) the manufacturer has implemented, and had assessed under clause 5.3 of this Schedule, a quality management system that is to be applied to the device; and (b) after assessment, the manufacturer plans to make: (i) a substantial change to the system; or (ii) a change to the kinds of medical devices to which the system is to be applied. (2) The manufacturer must: (a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and (b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 5.4 of this Schedule. (3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 5.3(2) of this Schedule in relation to the system or kinds of devices. (4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 5.4 of this Schedule. #### 5.6 Information to be given to authorised person (1) If requested to do so by an authorised person, the manufacturer of a medical device must: (a) give to the Secretary any of the following information in relation to the quality management system or the kinds of medical device to which the system is applied: (i) a copy of the documentation mentioned in subclause 5.4(5) of this Schedule; (ii) the quality records in relation to the final inspection and testing of the kinds of medical device to which the system is applied (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and (b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively. (2) If any inspections or tests are carried out by an authorised person in relation to the manufacturer’s premises, or medical devices manufactured by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests. #### 5.7 Declaration of conformity (1) The manufacturer of a Class IIb medical device to which a quality management system that has been assessed under clause 5.3 of this Schedule has been applied must make a declaration of conformity in relation to the kind of device. > Note: This clause need not be applied to the following kinds of medical devices if the declaration of conformity (not requiring assessment by Secretary) procedures have been applied to the device: (a) a Class IIa medical device (see Division 3.2, subparagraph 3.8(1)(b)(iii)); (b) a Class I medical device that has a measuring function (see Division 3.2, paragraph 3.9(3)(c)). (2) The declaration must: (a) state that the declaration is a declaration of conformity made under clause 5.7 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and (b) state the name and business address of the manufacturer of the device; and (c) state the following information in relation to each kind of medical device to which the system has been applied: (i) the unique product identifier; (ii) the medical device classification; (iii) the device nomenclature system code; and (d) if the system has not been applied to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the system has been applied (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and (e) for a kind of device in relation to which the type examination procedures have been applied—state that: (i) the type examination procedures have been applied to the kind of device; and (ii) the kind of device conforms to the approved type; and (f) for a kind of device to which the declaration of conformity (not requiring assessment by Secretary) procedures have been applied—state that the kind of device is in accordance with the technical documentation prepared under clause 6.4 of those procedures for the kind of device; and (g) state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the system or the kind of medical devices to which the system has been applied; and (h) give details of any conformity assessment standard that has been applied to the system; and (i) be signed by a person authorised by the manufacturer; and (j) set out the name and position of the person signing the declaration; and (k) state the date when the declaration is signed. #### 5.8 Records (1) The manufacturer of a kind of medical device to which a quality management system that has been assessed under clause 5.3 of this Schedule has been applied must keep the following records in relation to the system and the kind of device: (a) the documentation mentioned in subclause 5.4(5) of this Schedule; (b) details of any changes made to the system and to the information and documentation required under subclause 5.5(3) of this Schedule; (c) details of any changes made to the kinds of medical devices to which the system was applied; (d) for a Class IIb medical device—the declaration of conformity under clause 5.7 of this Schedule; (e) any notice, report, certificate or other document in relation to the system issued to the manufacturer by the Secretary or an Australian conformity assessment body. (2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the quality management system was applied. (3) On request from the Secretary, the manufacturer must make the records available to the Secretary. ## Part 6—Declaration of conformity (not requiring assessment by Secretary) procedures #### 6.1 Overview The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device: (a) to prepare technical documentation in relation to the kind of device to enable assessment of the device; and (b) to make a declaration of conformity in relation to the kind of device; and (c) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system. > Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied. #### 6.2 References to kinds of medical devices A reference in this Part to a kind of medical device includes a reference to an individual medical device. #### 6.3 Implementation (1) The manufacturer of a medical device must prepare technical documentation in relation to the kind of device in a form that, if the Secretary decides to do so, would allow the Secretary to assess whether the device complies with the applicable provisions of the essential principles, the classification rules and these conformity assessment procedures. (2) For the purpose of enabling an assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings: (a) the name and business address of the manufacturer; (b) details of each manufacturing site where these conformity assessment procedures are to be applied; (c) all relevant information required to identify the kinds of medical devices to which these conformity assessment procedures are to be applied; (d) an undertaking by the manufacturer to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in subparagraph 6.5(2)(c)(i) or (ii) that the manufacturer becomes aware of in relation to a kind of medical device. #### 6.4 Required technical documentation (1) The technical documentation must include adequate information in relation to the kind of device, and must include, in particular, the following: (a) a general description of the kind of device, and of any variants of the kind of device that the manufacturer plans to manufacture; (b) diagrams or drawings of the design of the kind of device, including diagrams or drawings of any components, sub‑assemblies or circuits of the kind of device; (c) any descriptions or explanations that are necessary to enable the diagrams or drawings mentioned in paragraph (b), or the intended operation of the kind of device, to be properly understood; (d) if the kind of device is intended by the manufacturer to be supplied in a sterile state—a description of the method used to sterilise the kind of device; (e) details of each medical device standard or conformity assessment standard that has been applied, wholly or in part, to the kind of device; (f) if no medical device standard or conformity assessment standard has been applied, or a medical device standard or conformity assessment standard has been only partly applied, to the kind of device—the solutions adopted to ensure that each device complies with the applicable provisions of the essential principles; (g) the results of any design calculations, risk analyses, investigations, technical tests, or any other tests, carried out in relation to the kind of device; (h) if the kind of device is intended by the manufacturer to be connected to another device—evidence demonstrating that the device will comply with the applicable provisions of the essential principles when it is connected to the other device and both devices are being used for their intended purposes; (i) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures; (j) a copy of the information to be provided with the kind of device. (2) If the manufacturer makes a change to the design or the production of the kind of medical device after the technical documentation has been prepared (for example, because it was necessary to apply corrective action in relation to the kind of device), the manufacturer must revise the technical documentation to take account of the change. #### 6.5 Post‑marketing system (1) The manufacturer of a medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must establish, and keep up‑to‑date, a post‑marketing system that complies with subclause (2) for use in relation to devices of that kind. (2) A post‑marketing system complies with this subclause in relation to a medical device if the system requires the manufacturer of the device: (a) to systematically review experience gained in the post‑production phase in relation to medical devices of that kind; and (b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices; and (c) to notify the Secretary, or the person in relation to whom the kind of device is included in the Register, as soon as practicable after becoming aware of: (i) information relating to: (A) any malfunction or deterioration in the characteristics or performance of the kind of device; or (B) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or (C) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device; that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health; or (ii) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed. > Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary. #### 6.6 Declaration of conformity (1) The manufacturer of a kind of medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must make a declaration of conformity in relation to the kind of device. (2) The declaration must: (a) state that the declaration is a declaration of conformity made under clause 6.6 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and (b) state the name and business address of the manufacturer of the device; and (c) state the following information in relation to each kind of medical device to which the technical documentation applies: (i) the unique product identifier; (ii) the medical device classification; (iii) the device nomenclature system code; and (d) if the technical documentation applies to a Class IIa medical device that the manufacturer intends to be supplied in a sterile state or a Class I medical device that the manufacturer intends to be supplied in a sterile state—state that the production quality assurance procedures have also been applied to the device; and (e) if the technical documentation applies to a Class IIa medical device that the manufacturer intends to be supplied in a non‑sterile state, or a Class I medical device that has a measuring function and that the manufacturer intends to be supplied in a non‑sterile state—state which of the following conformity assessment procedures have also been applied to the device: (i) the verification procedures; (ii) the production quality assurance procedures; (iii) the product quality management system procedures; and (f) if the technical documentation does not apply to all medical devices of that kind manufactured by the manufacturer—give details of the medical devices to which the technical documentation applies (for example, by reference to lot numbers, batches or serial numbers, or by specifying the kinds of medical devices or the times of manufacture); and (g) state that each kind of medical device to which the technical documentation applies complies with the applicable provisions of the essential principles, the classification rules, and these procedures; and (h) if the technical documentation applies to any of the following kinds of medical devices: (i) a Class IIa medical device; (ii) a Class 2 IVD medical device; (iii) a Class I medical device that the manufacturer intends to be supplied in a sterile state; (iv) a Class I medical device that has a measuring function; state the identification number of the conformity assessment certificate, or of the Australian conformity assessment body certificate, issued in relation to the kind of medical device, or the quality management system that has been applied to the kind of device, as a result of the application to the device of the conformity assessment procedures set out in Part 3, 4 or 5 of this Schedule; and (i) give details of any medical device standard or conformity assessment standard that has been applied to the device; and (j) be signed by a person authorised by the manufacturer; and (k) set out the name and position of the person signing the declaration; and (l) state the date when the declaration is signed. #### 6.7 Records (1) The manufacturer of a medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must keep the following records: (a) the technical documentation prepared under clause 6.4 of this Schedule, including any revisions of the documentation prepared as a result of changes to the design or production of the kind of device; (b) details of any changes made to the design or production of the kind of medical device and to the documentation required under clause 6.4 of this Schedule; (c) the declaration of conformity under clause 6.6 of this Schedule. (2) The manufacturer must keep the records for at least 5 years after the manufacture of the last medical device to which the technical documentation prepared clause 6.4 of this Schedule applies. (3) On request from the Secretary, the manufacturer must make the records available to the Secretary. ## Part 6A—Procedures applying to Class 1, 2 and 3 in‑house IVD medical devices #### 6A.1 Overview The conformity assessment procedures set out in this Part provide for the manufacturer of a Class 1 in‑house IVD medical device, Class 2 in‑house IVD medical device or Class 3 in‑house IVD medical device to do the following: (a) implement procedures relating to the application of a quality management system to the manufacture of the device; (b) provide information to the Secretary about the quality management system and the device; (c) establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system. #### 6A.2 Procedures Notification of devices being manufactured (1) The manufacturer of a Class 1 in‑house IVD medical device, Class 2 in‑house IVD medical device or Class 3 in‑house IVD medical device must notify the Secretary, in accordance with subclauses (2) and (3), of all the Class 1, 2 or 3 in‑house IVD medical devices being manufactured. (2) A notification under subclause (1) must: (a) be in a form approved in writing by the Secretary; and (b) contain the information required by the form; and (c) cover each Class 1, 2 or 3 in‑house IVD medical device being manufactured at the time the notification is given. (3) A notification under subclause (1) must be given to the Secretary: (a) if the manufacturer manufactures one or more Class 1, 2 or 3 in‑house IVD medical devices before 1 July 2017—no later than 20 working days after 1 July 2017; and (b) if, in a financial year, the manufacturer starts to manufacture a Class 1, 2 or 3 in‑house IVD medical device not covered by the most recent of any previous notification given to the Secretary under subclause (1)—by the later of the following: (i) 1 July of the next financial year; (ii) 20 working days after manufacturing the device for the first time. Accreditation requirements etc. (4) The laboratory in which the Class 1, 2 or 3 in‑house IVD medical device is manufactured must: (a) be accredited as a testing laboratory by NATA, or by a conformity assessment body determined by the Secretary, as meeting one of the following standards, as published by the International Organization for Standardization and as amended from time to time: (i) ISO 15189, Medical laboratories—Requirements for quality and competence; (ii) ISO/IEC 17025, General requirement for the competence of testing and calibration laboratories; and (b) meet the National Pathology Accreditation Advisory Council standard Requirements for the Development and Use of in‑house In Vitro Diagnostic Devices (IVDs), as amended from time to time. #### 6A.3 Information to be given to the Secretary (1) On request by an authorised person, the manufacturer of a Class 1, 2 or 3 in‑house IVD medical device must: (a) give to the Secretary, within the period specified in the request (which must not be less than 20 working days after the request is made), the following information in relation to the device and the quality management system applied to the device: (i) a copy of the documentation mentioned in subclause (2); (ii) data for the design of the device (for example, the results of any analysis of the device, calculations or tests); (iii) data for the manufacture of the device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and (b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively. (2) The documentation must include the following information: (a) the manufacturer’s quality objectives; (b) the organisation of the manufacturer’s business, including a description of the following: (i) the organisational structure of the business; (ii) the responsibilities of managerial staff and their authority in relation to the quality of the design and production of medical devices manufactured by the manufacturer; (iii) the methods of monitoring whether the system is operating effectively, including whether the desired quality of design and product is being achieved and how products that fail to meet the desired quality are controlled; (c) the design of the medical device to which the system is to be applied, including the following: (i) details of the processes, systems and measures used for controlling, monitoring and verifying that, at each stage of the design process, the device complies with the applicable provisions of the essential principles; (ii) a general description of the device; (iii) details of the design specifications for the device, including: (A) any medical device standard that has been applied to the device; and (B) the results of the risk analysis carried out; and (C) if no medical device standard, or part of it, has been applied to the device—the solutions adopted to ensure that each device complies with the applicable provisions of the essential principles; (iv) for a device that is intended by the manufacturer to be connected to another device—evidence demonstrating that the device will comply with the applicable provisions of the essential principles when it is connected to the other device and both devices are being used for their intended purposes; (v) a statement indicating whether or not the device contains viable tissues, cells or substances of human or animal origin; (vi) a copy of the clinical evidence, in relation to the device, required by the clinical evaluation procedures; (vii) a copy of the information to be provided with the device, when relevant; (d) the inspection and quality assurance techniques to be applied in the production of the medical device to which the system is to be applied, including information about the following: (i) the processes and procedures to be used and the documents relating to those processes and procedures; (ii) the procedures to be used for purchasing goods or services in relation to the production of the device and the documents relating to those procedures; (iii) product identification procedures to be prepared and kept up‑to‑date from drawings, specifications or other documents at each stage of production; (e) the tests or trials to be carried out before, during and after production of the medical device to which the system is to be applied, including information about: (i) the frequency with which the tests or trials are to be carried out; and (ii) the equipment (including the traceability of the calibration of the equipment) used, or to be used, to carry out the tests or trials; (f) the system for reviewing experience gained in the post‑production phase for the medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied to the design or production of such devices. (3) If any inspections or tests are carried out by an authorised person in relation to the manufacturer’s premises, or medical devices produced by the manufacturer, the manufacturer may ask the authorised person to give to the manufacturer a report stating the findings of the inspections or tests. #### 6A.4 Post‑marketing system (1) The manufacturer of a Class 1, 2 or 3 in‑house IVD medical device must establish, and keep up‑to‑date, a post‑marketing system for use for the device. (2) The post‑marketing system must require the manufacturer of the device to: (a) systematically review experience gained in the post‑production phase for the device; and (b) implement appropriate means to apply any necessary corrective action for the design or production of the device; and (c) notify the Secretary as soon as practicable after becoming aware of information relating to any of the following that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health: (i) any malfunction or deterioration in the characteristics or performance of the device; (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the device; (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the device. ## Part 6B—Procedures applying to Class 4 in‑house IVD medical devices #### 6B.1 Overview The conformity assessment procedures set out in this Part provide for the manufacturer of a Class 4 in‑house IVD medical device to do the following: (a) implement a quality management system for the design, production, packaging, labelling and final inspection of that kind of device; (b) prepare technical documentation in relation to that kind of device; (c) establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system; (d) make a declaration of conformity in relation to that kind of device; (e) prepare and keep records in relation to these procedures; (f) notify the Secretary of the manufacture of certain Class 4 in‑house IVD medical devices. #### 6B.2 References to kinds of medical devices A reference in this Part to a kind of medical device includes a reference to an individual medical device. #### 6B.3 Procedures (1) The manufacturer of a Class 4 in‑house IVD medical device must implement a quality management system for the design, production, packaging, labelling and final inspection of that kind of device. (2) If the kind of device is used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods, either: (a) the manufacturer must: (i) satisfy the requirements in the Australian Code of Good Manufacturing Practice for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products, published by the Therapeutic Goods Administration, as amended from time to time; and (ii) hold a manufacturing licence that is in force and authorises the carrying out of a step in the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods; or (b) the laboratory in which the kind of device is manufactured must: (i) be accredited as a testing laboratory by NATA as meeting ISO 15189, Medical laboratories—Requirements for quality and competence, published by the International Organization for Standardization, as amended from time to time; and (ii) meet the National Pathology Accreditation Advisory Council standard Requirements for the Development and Use of in‑house In Vitro Diagnostic Devices (IVDs), as amended from time to time. (3) If the kind of device is not used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods, the laboratory in which the kind of device is manufactured must: (a) be accredited as a testing laboratory by NATA as meeting ISO 15189, Medical laboratories—Requirements for quality and competence, published by the International Organization for Standardization, as amended from time to time; and (b) meet the National Pathology Accreditation Advisory Council standard Requirements for the Development and Use of in‑house In Vitro Diagnostic Devices (IVDs), as amended from time to time. #### 6B.4 Required technical documentation (1) The manufacturer of a Class 4 in‑house IVD medical device must have available technical documentation for that kind of device that: (a) is up‑to‑date; and (b) is in a form that, if requested by the Secretary, would allow an assessment to be carried out as to whether a device of that kind complies with the applicable provisions of the essential principles, the classification rules, and these conformity assessment procedures; and (c) contains the information mentioned in subclauses (2) and (3). (2) The technical documentation must contain information about the kind of device in relation to which the quality management system mentioned in subclause 6B.3(1) of this Part is to be applied, including the following: (a) details of the processes, systems and measures used for controlling, monitoring and verifying that the kind of device complies with the applicable provisions of the essential principles; (b) a general description of the kind of device; (c) details of the design specifications for the kind of device, including: (i) any medical device standard that has been applied to the kind of device; and (ii) the results of the risk analysis carried out; and (iii) if no medical device standard, or part only of such a standard, has been applied to the kind of device—the solutions adopted to ensure that each device of that kind complies with the applicable provisions of the essential principles; (d) for a kind of device that is intended by the manufacturer to be connected to another device—evidence demonstrating that: (i) the kind of device will comply with the applicable provisions of the essential principles when it is connected to the other device; and (ii) both devices are being used for their intended purposes; (e) a statement indicating whether or not the kind of device contains viable tissues, cells or substances of human or animal origin; (f) the results of any calculations, investigations, technical tests, or any other tests, carried out by the manufacturer in relation to the kind of device; (g) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures; (h) a copy of the information to be provided with the kind of device (if any). (3) The technical documentation must also contain information about the method or methods of manufacture of the kind of device. #### 6B.5 Post‑marketing system (1) The manufacturer of a Class 4 in‑house IVD medical device must establish, and keep up‑to‑date, a post‑marketing system for use for a device of that kind. (2) The post‑marketing system must require the manufacturer to: (a) systematically review experience gained in the post‑production phase for devices of that kind; and (b) implement appropriate means to apply any necessary corrective action for the design or production of those devices; and (c) notify the Secretary as soon as practicable after becoming aware of information relating to any of the following that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health: (i) any malfunction or deterioration in the characteristics or performance of the kind of device; (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device. #### 6B.6 Declaration of conformity (1) The manufacturer of a Class 4 in‑house IVD medical device to which these conformity assessment procedures have been applied must make a declaration of conformity in relation to the kind of device. (2) The declaration must: (a) state that the declaration is a declaration of conformity made under clause 6B.6 of Part 6B of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and (b) state the name and business address of the manufacturer of the device; and (c) state the following information for the kind of device in relation to which the quality management system mentioned in subclause 6B.3(1) of this Part has been applied: (i) the unique product identifier; (ii) the medical device classification; (iii) the device nomenclature system code; and (d) state that the kind of device in relation to which the quality management system has been applied complies with the applicable provisions of the essential principles, the classification rules, and these conformity assessment procedures; and (e) if the kind of device is used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods—either: (i) state that the manufacturer satisfies the requirements in the Australian Code of Good Manufacturing Practice for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products, as mentioned in subparagraph 6B.3(2)(a)(i), and state the number of the manufacturing licence held by the manufacturer, as mentioned in subparagraph 6B.3(2)(a)(ii); or (ii) state that the laboratory in which the kind of device is manufactured meets the requirements mentioned in subparagraphs 6B.3(2)(b)(i) and (ii), and state the NATA accreditation number issued to the laboratory; and (f) if the kind of device is not used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods—state that the laboratory in which the kind of device is manufactured meets the requirements mentioned in paragraphs 6B.3(3)(a) and (b), and state the NATA accreditation number issued to the laboratory; and (g) be signed by a person authorised by the manufacturer; and (h) set out the name and position of the person signing the declaration; and (i) state the date when the declaration is signed. #### 6B.7 Records (1) The manufacturer of a Class 4 in‑house IVD medical device to which these conformity assessment procedures have been applied must keep the following records in relation to the procedures and the kind of device: (a) the technical documentation mentioned in clause 6B.4 of this Part; (b) details of any changes made to the kind of device and to the technical documentation in relation to the design or production of the kind of device; (c) the declaration of conformity under clause 6B.6 of this Part; (d) details of any systematic review carried out, after production, in relation to devices of that kind. (2) The manufacturer must keep the records for at least 5 years after the manufacturer stops manufacturing devices of that kind. (3) On request from the Secretary, and within such reasonable period as is set out in the request, the manufacturer must make the records available to the Secretary. #### 6B.8 Notification of certain Class 4 in‑house IVD medical devices being manufactured (1) The manufacturer of a kind of Class 4 in‑house IVD medical device that the manufacturer intends to be used to detect the presence of, or exposure to, transmissible agents in blood, stool or other specimens from a person’s body in order to assess the suitability of the person to be a donor of human stool for use in the manufacture of a faecal microbiota transplant product must notify the Secretary, in accordance with subclauses (2) and (3), about that kind. (2) A notification under subclause (1) must: (a) be in a form approved in writing by the Secretary; and (b) contain the information required by the form. (3) A notification under subclause (1) must be given to the Secretary: (a) if the manufacturer manufactures such a kind of Class 4 in‑house IVD medical device on or after the commencement of this clause and before 1 July 2021—no later than 20 working days after 1 July 2021; and (b) if, on or after 1 July 2021, the manufacturer manufactures such a kind of Class 4 in‑house IVD medical device—no later than 20 working days after the manufacture. (4) Only one notification is required under this clause in relation to each kind of Class 4 in‑house IVD medical device manufactured by a manufacturer. ## Part 7—Procedures for medical devices used for a special purpose #### 7.1 Overview The conformity assessment procedures set out in this Part provide for the manufacturer of a medical device used for a special purpose: (a) to prepare a written statement containing certain information in relation to the device and to provide a copy of the statement with the device; and (b) to prepare and keep up‑to‑date particular documentation in relation to the device. #### 7.2 Custom‑made medical devices (1) This clause applies to a custom‑made medical device. (2) The manufacturer of the device must prepare a written statement in relation to the device including the following: (a) the name and business address of the manufacturer; (b) sufficient information to enable the user to identify the device or, if relevant, the contents of packaging; (c) a statement to the effect that the device is intended by the manufacturer to be for the sole use of a particular patient or health professional; (d) the name of the individual in relation to whom the device is intended to be used; (e) the name and business address of the health professional who made the request for the device; (f) the particular design characteristics of the device as specified by the health professional who made the request for the device; (g) a statement to the effect that the device complies with the applicable provisions of the essential principles or, if the device does not comply with all applicable provisions of the essential principles, a statement explaining which provisions of the essential principles the device does not comply with and the reasons for the non‑compliance. (3) The statement must: (a) be signed by a person authorised by the manufacturer of the device; and (b) set out the name and position of the person signing the statement; and (c) state the date when the statement is signed. (3A) The manufacturer must provide a copy of the statement with the device. (4) The manufacturer must prepare, and keep up‑to‑date, documentation in relation to the device, including information in relation to the design, production and intended performance of the device. (5) The manufacturer must take all measures necessary to ensure that the process used to manufacture the device results in the device complying with the documentation mentioned in subclause (4). (6) The manufacturer must notify the Secretary as soon as practicable after becoming aware of: (a) information relating to: (i) any malfunction or deterioration in the characteristics or performance of the device; or (ii) any inadequacy in the design, production, labelling or instructions for use of the device; or (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the device; that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health; or (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in paragraph (a) that has led the manufacturer to take steps to recall a device that has been distributed. > Note: Clauses 7.3 and 7.4 are intentionally not used. #### 7.5 System or procedure packs (1) The manufacturer of a system or procedure pack must make a declaration of conformity in relation to the system or procedure pack. (2) The declaration must: (a) state that the declaration is a declaration of conformity made under clause 7.5 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002; and (b) state the name and business address of the manufacturer of the system or procedure pack; and (c) state sufficient information to enable the user to identify the system or procedure pack or the contents of the system or procedure pack; and (d) identify each item in the system or procedure pack; and (e) except in relation to a medical device covered by paragraph (ia)—state that the manufacturer has: (i) a conformity assessment document, a declaration of conformity under clause 6.6 or a statement under subclause 7.2(2) for each medical device in the system or procedure pack for which such a document, declaration or statement is required; and (ii) evidence that each medical device in the system or procedure pack complies with the applicable provisions of the essential principles; and (f) state the registration or listing number for each medicine or other therapeutic goods, or the biological number for each biological, in the system or procedure pack; and (g) state that each medical device in the system or procedure pack is intended to be used for its original intended purpose, and each medicine, biological or other therapeutic goods in the system or procedure pack is intended to be used within the approved indications of the medicine, biological or other therapeutic goods; and (h) state that the mutual compatibility of each medical device, medicine, biological or other therapeutic goods, and any other goods, in the system or procedure pack has been verified in accordance with: (i) the instructions for use of each medical device included in the system or procedure pack, being the instructions for use provided by the manufacturer of the device; and (ii) the approved indications of each medicine, biological and other therapeutic goods (if any) included in the system or procedure pack; and (ha) state that the manufacturer of the system or procedure pack has manufactured the system or procedure pack in accordance with the instructions referred to in subparagraph (h)(i) and the indications referred to in subparagraph (h)(ii); and (i) state that the information supplied with the system or procedure pack for the use of the system or procedure pack includes instructions for use provided by the manufacturer of each item in the system or procedure pack; and (ia) if the manufacturer of the system or procedure pack has modified the packaging of any medical device included in the system or procedure pack or modified any medical device included in the system or procedure pack—state the matters covered by subclause (2A); and (j) state that the process of manufacturing the system or procedure pack, and the verification and packaging (if any) of the system or procedure pack, has been subjected to a documented method of internal control and inspection that ensures the safety, quality, performance and effectiveness of each item in the system or procedure pack; and (k) if the system or procedure pack is intended by the manufacturer to be supplied in a sterile state—state that the full quality assurance procedures (other than clause 1.6), or the production quality assurance procedures (other than clause 4.7), have been applied to the system or procedure pack in accordance with: (i) the instructions for use of each medical device included in the system or procedure pack, being the instructions for use provided by the manufacturer of the device; and (ii) the approved indications of each medicine, biological and other therapeutic goods (if any) included in the system or procedure pack; and (l) be signed by a person authorised by the manufacturer; and (m) set out the name and position of the person signing the declaration; and (n) state the date when the declaration is signed. (2A) For the purposes of paragraph (2)(ia), the matters are the following: (a) that the modification has not affected the quality, safety or performance of the medical device; (b) if the modification has not been done in accordance with the instructions for use of the medical device provided by the manufacturer of the device—that the manufacturer of the system or procedure pack has: (i) if a conformity assessment document, a declaration of conformity under clause 6.6 or a statement under subclause 7.2(2) is required for the medical device—such a document, declaration or statement for the medical device, as affected by the modification; and (ii) evidence that the medical device, as affected by the modification, complies with the applicable provisions of the essential principles. (2B) If the manufacturer of a system or procedure pack has modified the packaging of any medical device included in the system or procedure pack or modified any medical device included in the system or procedure pack: (a) the manufacturer of the system or procedure pack must ensure that the modification does not affect the quality, safety or performance of the medical device; and (b) if the modification has not been done in accordance with the instructions for use of the medical device provided by the manufacturer of the device—the manufacturer of the system or procedure pack must have: (i) if a conformity assessment document, a declaration of conformity under clause 6.6 or a statement under subclause 7.2(2) is required for the medical device—such a document, declaration or statement for the medical device, as affected by the modification; and (ii) evidence that the medical device, as affected by the modification, complies with the applicable provisions of the essential principles. (3) The manufacturer of a system or procedure pack must establish, and keep up‑to‑date, a post‑marketing system that complies with subclause (4) for use in relation to the system or procedure pack. (4) A post‑marketing system complies with this subclause in relation to a system or procedure pack if the post‑marketing system requires the manufacturer of the system or procedure pack: (a) to systematically review experience gained in the post‑production phase in relation to the system or procedure pack; and (b) to implement appropriate means to apply any necessary corrective action in relation to the production of the system or procedure pack; and (c) to notify the Secretary as soon as practicable after becoming aware of: (i) information relating to: (A) any malfunction or deterioration in the characteristics or performance of the system or procedure pack; or (B) any inadequacy in the production, labelling, instructions for use or advertising materials of the system or procedure pack; or (C) any use in accordance with, or contrary to, the use intended by the manufacturer of the system or procedure pack; that might lead, or might have led, to the death of a patient or a user of the system or procedure pack, or to a serious deterioration in his or her state of health; or (ii) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (i) that has led the manufacturer to take steps to recall system or procedure packs of that kind that have been distributed. > Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary. #### 7.6 Records (1) The manufacturer must keep the statement and documentation required under the relevant clause of this Schedule in relation to a medical device to which the conformity assessment procedures in this Part have been applied. (2) The manufacturer must keep the statement and documentation for at least: (a) if the device is not an implantable medical device—5 years after the manufacture of the medical device to which the statement and documentation relate; or (b) if the device is an implantable medical device—15 years after the manufacture of the medical device to which the statement and documentation relate. (3) On request from the Secretary, the manufacturer must make the statement and documentation available to the Secretary. ## Part 8—Clinical evaluation procedures #### 8.1 Overview The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device to obtain and evaluate clinical data in relation to the kind of device. > Note: See regulation 3.11 in relation to the kinds of medical devices to which these conformity assessment procedures must be applied. #### 8.2 References to kinds of medical devices A reference in this Part to a kind of medical device includes a reference to an individual medical device. #### 8.3 Obtaining clinical data (1) The manufacturer of a kind of medical device must obtain clinical data in relation to the device in the form of either or both of the following: (a) clinical investigation data in accordance with clause 8.4; (b) a literature review in accordance with clause 8.5. (2) The manufacturer must ensure that the clinical data obtained takes account of any medical device standard or conformity assessment standard that may apply to the device. #### 8.4 Clinical investigation data (1) For clause 8.3, clinical investigation data, in relation to a kind of medical device, includes: (a) documentation in relation to the design, approval, conduct and results of each investigation carried out by the manufacturer of the device in relation to the use of the device in or on a human body; and (b) a record of qualitative or quantitative information obtained through observation, measurement, tests or any other means used to assess the operation of the device; and (c) a written report by an expert in the relevant field, being a report that contains a critical evaluation of all the clinical investigation data held in relation to the device. (2) The documentation mentioned in paragraph (1)(a) must be in a form that allows the manufacturer to evaluate whether the device complies with the applicable provisions of the essential principles. (3) The record mentioned in paragraph (1)(b) must be in a form that allows the information in it to be independently assessed and verified. (4) If clinical investigation data is collected in Australia, the investigation must have been conducted in accordance with the ethical standards set out in the ‘National Statement on Ethical Conduct in Research Involving Humans’, published by the National Health and Medical Research Council, as in force from time to time. (5) If clinical investigation data is collected outside Australia, the investigation must have been conducted in accordance with the principles of the Declaration of Helsinki, as in force at the time and place where the investigation was conducted. #### 8.5 Literature review For clause 8.3, a literature review, in relation to a kind of medical device, includes: (a) a compilation, prepared using a documented methodology, of published literature and unpublished scientific literature, both favourable and unfavourable, relating to medical devices of that kind, including the following: (i) expert opinion; (ii) information about the hazards and associated risks arising from the use of the device for its intended purpose, and the foreseeable misuse of the device; (iii) information about the performance of devices of that kind, including a description of the techniques used to examine whether devices of that kind achieve their intended purpose; and (b) a written report by an expert in the relevant field, being a report that contains a critical evaluation of the compilation of literature mentioned in paragraph (a). #### 8.6 Evaluation of clinical data (1) The manufacturer of a kind of medical device must ensure that the clinical data is evaluated by competent clinical experts. (2) The manufacturer must ensure that clinical evidence demonstrating that the device complies with the applicable provisions of the essential principles is documented in writing. Schedule 3AA—Requirements for Australian conformity assessment bodies Note: See Part 4A. #### 1 Purpose of this Schedule This Schedule sets out requirements for the purposes of making, suspending, revoking or varying a conformity assessment body determination under Part 4A of these Regulations. #### 2 EU Regulations (1) The requirements are: (a) to the extent the determination covers medical devices that are not IVD medical devices—the requirements of the EU medical devices regulation, as modified by clauses 3, 4 and 5 of this Schedule; and (b) to the extent the determination covers IVD medical devices—the requirements of the EU IVD regulation, as modified by clauses 3, 4 and 6 of this Schedule. (2) The EU medical devices regulation is Annex VII to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force from time to time. (3) The EU IVD regulation is Annex VII to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force from time to time. #### 3 Modifications of EU Regulations—general (1) For the purposes of subclause 2(1), the EU medical devices regulation and the EU IVD regulation (the EU regulations) are taken to be modified as set out in this clause. General modifications (2) A reference in the EU regulations to a term mentioned in column 1 of an item of the following table is taken to be a reference to the term mentioned in column 2 of that item. ```html <table cellspacing="0" cellpadding="0" style="border-collapse:collapse"><thead><tr><td colspan="3" style="width:410.55pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Modifications</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p><p class="TableHeading"><span>Term used in the EU regulations</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p><p class="TableHeading"><span>Substituted term</span></p></td></tr></thead><tbody><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="page-break-inside:avoid; page-break-after:avoid"><span>1</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea" style="page-break-inside:avoid; page-break-after:avoid"><span>(a) Union; or</span></p><p class="Tablea" style="page-break-inside:avoid; page-break-after:avoid"><span>(b) national; or</span></p><p class="Tablea" style="page-break-inside:avoid; page-break-after:avoid"><span>(c) Union and national</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="page-break-inside:avoid; page-break-after:avoid"><span>Australian</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1A</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) a Member State; or</span></p><p class="Tablea"><span>(b) the Member State; or</span></p><p class="Tablea"><span>(c) that Member State</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Australia</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) a competent authority; or</span></p><p class="Tablea"><span>(b) competent authorities; or</span></p><p class="Tablea"><span>(c) the Commission; or</span></p><p class="Tablea"><span>(d) the MDCG</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>the Secretary</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>notified body</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Australian conformity assessment body</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3A</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>notified bodies</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><a id="_Hlk133491386"><span>Australian conformity assessment bodies</span></a></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>authorised representative</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>sponsor</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) this Regulation; or</span></p><p class="Tablea"><span>(b) Union devices legislation; or</span></p><p class="Tablea"><span>(c) this Annex</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>these Regulations</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>notification requirements laid down in Chapter V of this Regulation</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>applicable requirements under these Regulations to notify the Secretary</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) general safety and performance requirements set out in Annex I; or</span></p><p class="Tablea"><span>(b) requirements in Annex I; or</span></p><p class="Tablea"><span>(c) requirements laid down in Annex I</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>essential principles</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) Annexes IX to XI; or</span></p><p class="Tablea"><span>(b) the relevant conformity assessment Annex</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Schedule</span><span> </span><span>3 to these Regulations</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>Annex X</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>the type examination procedures in Part</span><span> </span><span>2 of Schedule</span><span> </span><span>3 to these Regulations</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>11</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>minimum requirements laid down in Annex XII</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>requirements of these Regulations</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>13</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>harmonised standards</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>conformity assessment standards and medical device standards</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>14</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>conformity assessment activities</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>certification</span><span>‑</span><span>related activities</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>15</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) post</span><span>‑</span><span>market surveillance; or</span></p><p class="Tablea"><span>(b) post</span><span>‑</span><span>market surveillance plan</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>post</span><span>‑</span><span>marketing requirements mentioned in Schedule</span><span> </span><span>3 to these Regulations</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>16</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>class B device</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Class 2 IVD medical device</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>17</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>class C device</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Class 3 IVD medical device</span></p></td></tr><tr><td style="width:21.4pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>18</span></p></td><td style="width:193pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>shall</span></p></td><td style="width:174.55pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>must</span></p></td></tr></tbody></table> ``` (3) Subclause (2) has effect subject to subclause (6) and clauses 5 and 6. > Note: Example: Item 4 of the table in subclause (2) does not apply to the reference to “authorised representative” in Section 4.3 of each EU regulation (see subparagraph (6)(c)(i) of this clause). (4) For the purposes of the EU regulations: (a) an activity is taken to be designated, in relation to an Australian conformity assessment body, if the activity relates to conformity assessment procedures covered by the body’s conformity assessment body determination; and (b) a device is taken to be designated, in relation to an Australian conformity assessment body, if the device is covered by the body’s conformity assessment body determination. (5) A reference in the EU regulations to CS is disregarded. > Note: CS is short for common specifications. Modifications of specific provisions (6) Each EU regulation is taken to be modified in the following ways: (a) the following provisions are disregarded: (i) Sections 1.1.1, 1.2.6 and 1.2.8; (ii) the words “unless liability is assumed by the Member State in question in accordance with national law or that Member State is directly responsible for their conformity assessment” in Section 1.4.1; (iii) the words “or previously applicable law within a notified body” in Section 3.2.3; (vi) the words “as referred to in Annexes II and III” in point (a) of Section 4.5.2; (vii) all the words after “resultant decision” in Section 4.8; (b) in Section 3.1.1: (i) the words “performance and safety of devices” are replaced with the words “compliance with the essential principles”; and (ii) the words “those set out in Annex I” are replaced with the words “the essential principles”; (ba) in Section 3.3.1, the words “the authority responsible for notified bodies” are replaced with the words “the Secretary”; (c) in Section 4.3: (i) a reference to an authorised representative is taken to be a reference to an applicant authorised by the manufacturer; and (ii) a reference to the corresponding Annex is taken to be a reference to the corresponding part of Schedule 3 to these Regulations; and (iii) the word “approval” is replaced with the word “assessment”; (d) in Section 4.5.1, a reference to relevant Annexes is taken to be a reference to Schedule 3 to these Regulations; (da) in Section 4.5.2, the words “post‑market surveillance information” are replaced with the words “information from post‑marketing requirements mentioned in Schedule 3 to these Regulations”; (e) in Section 4.5.3, the words “For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX” are replaced with the words “For the assessment of compliance of manufacturers with clause 1.6 of Schedule 3 to these Regulations”; (ea) in Section 4.6, the words “personnel in designating authorities” are replaced with the words “the Secretary”; (f) in Section 4.10: (ii) the words “laid down in the relevant Annexes” are replaced with the words “for a quality management system set out in Schedule 3 for the conformity assessment procedure applied by the manufacturer”; and (iii) the words “summary of safety and performance” are replaced with the words “evidence of compliance with the essential principles”; (g) in Section 4.11, the word “reviews” (wherever occurring) is replaced with the word “assessments”. #### 4 Additional requirements (1) For the purposes of subclause 2(1), the EU medical devices regulation and the EU IVD regulation (the EU regulations) are taken to include the requirements mentioned in this clause. Independence and impartiality (2) Section 1.2 of each EU regulation includes a requirement that an Australian conformity assessment body will take action: (a) to respond to any threats to its impartiality; and (b) to ensure that all internal or external personnel or committees who could influence the body’s certification‑related activities will: (i) act impartially; and (ii) not allow commercial, financial or other pressures to compromise impartiality. Liability (3) Section 1.4 of each EU regulation includes a requirement that an Australian conformity assessment body will: (a) document a justification for the cover and overall financial value of the liability insurance mentioned in that Section, including: (i) the types of medical devices and conformity assessment procedures in relation to which the body carries on certification‑related activities; and (ii) the locations at which those activities are carried on; and (iii) the patient risk profile of the devices; and (iv) the compliance risk profiles of the manufacturing activities in relation to which the body carries on certification‑related activities; and (b) give this justification to the body’s liability insurer, and document having done so. Process requirements (4) Section 4 of each EU regulation includes a requirement that an Australian conformity assessment body will have documented procedures in place that cover the following in relation to the body’s certification‑related activities: (a) assigning internal or external personnel to activities on the basis of their documented competences; (b) following up corrections and corrective actions by manufacturers in relation to nonconformities identified during audits or assessments. #### 5 Additional modifications of EU medical devices regulations (1) For the purposes of subclause 2(1), the EU medical devices regulation is taken to be modified as set out in this clause. (2) A reference in the EU medical devices regulation to PMCF is disregarded. > Note: PMCF is short for post‑market clinical follow‑up. (3) The EU medical devices regulation is modified in the following ways: (a) the following provisions are disregarded: (i) the last dash point of Section 1.1.6; (ii) the words “the authorities responsible for notified bodies, competent authorities for medical devices in the Member States or” in Section 1.3.2; (iii) the sentence “Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 57 and shall be accessible to other notified bodies.” in Section 4.3; (iv) the eighth dash point of Section 4.5.1; (v) the words “referred to in Annexes II and III” in point (b) of Section 4.5.3; (vi) the words “as specified in Section 15 of Annex XI” in point (d) of Section 4.5.3; (vii) the words “as referred to in Regulation (EU) No 722/2012,” in Section 4.5.6; (viii) the words “for the relevant competent authority” in Section 4.5.6; (ix) the words “under Article 92(2)” in Section 4.10; (b) in Section 1.6.1, the words “notified body coordination group referred to in Article 49” are replaced with the word “Secretary”; (c) in Section 3.2.2, the words “Article 42(3)” are replaced with the words “Annex I of Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Commission Implementing (EU) 2017/2185)”; (d) in point (a) of Section 4.5.3, the words “Part B of Annex XI” are replaced with the words “Part 3 of Schedule 3 to these Regulations”; (e) in point (b) of Section 4.5.3, the words “the EU” are replaced with the words “a relevant”; (f) in Section 4.5.5, the words “Annex XIV” (wherever occurring) are replaced with the words “Part 8 of Schedule 3 to these Regulations”; (g) in Section 4.5.6: (i) the words “sufficient expertise and facilities for the procedures referred to in Sections 5 and 6 of Annex IX, Section 6 of Annex X and Section 16 of Annex XI, for which they are designated” are replaced with the words “allowing for external expert opinions to be sought when required to ensure an adequate assessment of compliance with these Regulations”; and (ii) the words “that Regulation” are replaced with the words “these Regulations”; (h) in Section 4.10, the words “observe the manufacturer’s and competent authority’s activities and the results of the manufacturer’s investigation” are replaced with the words “observe the manufacturer’s activities and the results of the manufacturer’s investigation, and be aware of information relating to the Secretary’s vigilance and monitoring activities that is available on the TGA’s website”. #### 6 Modifications of EU IVD regulations (1) For the purposes of subclause 2(1), the EU IVD regulation is taken to be modified as set out in this clause. (2) A reference in the EU IVD regulation to companion diagnostics or PMPF is disregarded. > Note: PMPF is short for post‑market performance follow‑up. (3) The EU IVD regulation is modified in the following ways: (a) the following provisions are disregarded: (i) point (g) of Section 1.1.6; (ii) the words “the authorities responsible for notified bodies, competent authorities for devices in the Member States or” in Section 1.3.2; (iii) the sentence “Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 52 and shall be accessible to other notified bodies.” in Section 4.3; (iv) the subsection headed “Verification by examination and testing of every product batch” in Section 4.5.3; (v) the paragraph beginning “In the case of companion diagnostics,” in Section 4.5.5; (vi) the words “under to Article 87” in Section 4.10; (b) in Section 1.6.1, the words “notified body coordination group referred to in Article 49 of Regulation (EU) 2017/745” are replaced with the word “Secretary”; (c) in Section 3.2.2: (i) the words “Article 38(3)” are replaced with the words “Annex II of Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro medical devices under Regulation (EU 2017/746 of the European Parliament and of the Council (Commission Implementing (EU) 2017/2185)”; and (ii) the words “self and near patient testing” are replaced with the words “self‑testing and point of care testing”; (d) in Section 4.5.5, the words “sufficient expertise and facilities for the procedures referred to in Section 5 of Annex IX, for which they are designated” are replaced with the words “allowing for external expert opinions to be sought when required to ensure an adequate assessment of compliance with the essential principles and these Regulations”; (e) in Section 4.10, the words “observe the manufacturer’s and competent authorities’ activities and the results of the manufacturer’s investigation” are replaced with the words “observe the manufacturer’s activities and the results of the manufacturer’s investigation, and be aware of information relating to the Secretary’s vigilance and monitoring activities that is available on the TGA’s website”; (f) a reference to a class B device is taken to be a reference to a Class 2 IVD medical device; (g) a reference to a class C device is taken to be a reference to a Class 3 IVD medical device. #### 7 Expressions used in modifications To avoid doubt, an expression used in a modification of the EU medical devices regulation or EU IVD regulation made by this Schedule has the same meaning in that modification as it does elsewhere in these Regulations. Schedule 3A—Disposal of unused emergency medical devices (regulation 6A.1) #### 1 Early end of exemption—notice of medical devices held (1) This clause applies if: (a) the Minister makes an exemption under section 41GS of the Act in relation to kinds of medical devices; and (b) a person is given a copy of a revocation or variation of the exemption under paragraph 41GV(b) of the Act. (2) The person must give the Secretary: (a) notice, in writing, of the quantity and location of: (i) for a revocation—the devices over which the person has control that have not been used; or (ii) for a variation—the devices mentioned in the variation over which the person has control that have not been used; and (b) a copy of any records about the devices that the person is required to keep under a condition of the exemption. (3) The person must comply with subclause (2) in relation to the devices within 7 days after the day the exemption ends for the devices. #### 2 End of exemption period—notice of medical devices held (1) This clause applies if an exemption under section 41GS of the Act ends because the period stated in the exemption ends. (2) A person who has been importing, manufacturing, supplying or exporting medical devices under the exemption must, within 7 days after the day the period ends, give the Secretary: (a) notice, in writing, of the quantity and location of any unused emergency medical devices over which the person has control; and (b) a copy of any records about the devices that the person is required to keep under a condition of the exemption. #### 3 Storage and disposal of unused emergency medical devices (1) A person who has control over unused emergency medical devices must ensure that the devices are stored in a way that ensures that: (a) the devices are only accessible for supply, export, use or disposal in accordance with the Act and these Regulations; and (b) the security of the devices is appropriate to the level of risk that the devices could pose to the public and the environment; and (c) the integrity of the condition of the devices is maintained. (2) A person may dispose of unused emergency medical devices only in accordance with a direction given by the Secretary under subclause 4(1). #### 4 Direction for disposal of unused emergency medical devices (1) The Secretary may direct, in writing, any person who has control over unused emergency medical devices to dispose of the devices in the way directed. (2) A direction under subclause (1) must be in accordance with clause 5, 6, 7 or 8. (3) A person who has been given a direction under subclause (1) must comply with the direction. #### 5 Relocation of unused emergency medical devices If storage of unused emergency medical devices at a place poses, or would pose, a risk to the public or the environment, the Secretary may direct that the devices be stored at a stated place that will ensure compliance with subclause 3(1). #### 6 Disposal of unused emergency medical devices—destruction (1) The Secretary may direct that unused emergency medical devices be destroyed within the time stated in the direction if any of the following applies: (a) the devices have passed their expiry date; (b) the devices no longer comply with the essential principles; (c) conformity assessment procedures were not applied to the devices and requirements, comparable to the conformity assessment procedures, were not applied to the devices; (d) use of the devices poses, or would pose, a risk to public health; (e) storage of the devices at their current location and any other location poses, or would pose, a risk to the public or the environment; (f) within 12 months after the exemption ends in relation to the devices, the devices have not become: (i) devices of a kind included in the Register under Part 4‑5 of the Act; or (ii) exempt devices under section 41HA of the Act; or (iii) devices that are the subject of an approval under section 41HB of the Act; or (iv) devices that are the subject of an authority under section 41HC of the Act; (g) the person who has control over the devices requests that the devices be destroyed. (2) A person directed to destroy the devices may destroy them only in a way, approved by the Secretary, that ensures that the destruction avoids or minimises harm to the public and the environment. #### 7 Disposal of unused emergency medical devices—export (1) This clause applies to unused emergency medical devices to which any of paragraphs 6(1)(a) to (e) applies. (2) The Secretary may direct that the devices be exported to a country, instead of directing that they be destroyed, if a relevant authority of the country has confirmed in writing its willingness to accept the devices. (3) A person directed to export the devices must ensure that, during exportation: (a) the devices are only accessible for purposes relating to the export; and (b) the security of the devices is appropriate to the level of risk that the devices could pose to the public and the environment; and (c) the integrity of the condition of the devices is maintained. #### 8 Disposal of unused emergency medical devices—supply (1) This clause applies to: (a) unused emergency medical devices that are a kind of medical device if: (i) an exemption under section 41GS of the Act in relation to that kind of medical device ceases to have effect other than because that kind of medical device becomes included in the Register under Part 4‑5 of the Act; and (ii) the devices later become devices of a kind included in the Register under Part 4‑5 of the Act; and (b) unused emergency medical devices that have become: (i) devices that are the subject of an approval under section 41HB of the Act; or (ii) devices that are the subject of an authority under section 41HC of the Act. (2) The Secretary may direct that the devices be supplied to an authorised person (otherwise than for therapeutic use on the person). (3) In this clause: > authorised person means: (a) for paragraph (1)(a)—the person in relation to whom the kind of medical device is included in the Register under Part 4‑5 of the Act; or (b) for an approval under section 41HB of the Act—the person to whom the approval is given; or (c) for an authority under subsection 41HC(1) of the Act—the person to whom the authority is given; or (d) for an authority given by rules made under subsection 41HC(6) of the Act—a health practitioner included in the class of health practitioners specified in the rules. #### 9 Owner to be paid for medical devices supplied A direction under clause 7 or 8 does not affect a person’s liability to pay the owner of the unused emergency medical devices for the export or supply of the devices to the person. #### 10 Records about unused emergency medical devices A person who has, or has had, control over unused emergency medical devices must: (a) ensure that records are kept that include the following information: (i) the quantities of the devices under the person’s control; (ii) how the devices are stored before being disposed of; (iii) if a direction under subclause 4(1) has been received—what actions have been taken to dispose of the devices as directed and when the actions were taken; (iv) if the devices have been exported or supplied—to whom they were exported or supplied and in what quantity; and (b) keep the records for 7 years after the last entry is made; and (c) if the Secretary asks the person, in writing, for a copy of a record mentioned in paragraph (a)—give the Secretary the copy: (i) within 14 days after the day the person is given the Secretary’s request; or (ii) if the information is required to establish whether the devices pose imminent risk to the public or the environment—within 24 hours, or any shorter period, stated by the Secretary. #### 11 Failure to comply with this Schedule If a person who has control over any unused emergency medical devices has not complied with a provision of this Schedule, the Secretary may direct a person, other than the person who has control over the devices, to destroy the devices in the way directed.