72‑11 Meaning of medical device72‑11 Meaning of medical device

72‑11 Meaning of medical device (1) A medical device is: (a) any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: (i) prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; (ii) monitoring, treatment, alleviation of or compensation for an injury or disability; (iii) investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; (iv) control or support of conception; (v) in vitro examination of a specimen derived from the human body for a specific medical purpose; and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or (b) any instrument, apparatus, appliance, software, implant, reagent, material or other article specified in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules; or (c) an *accessory to an instrument, apparatus, appliance, software, implant, reagent, material or other article covered by paragraph (a) or (b). (2) For the purposes of paragraph (1)(a), the purpose for which an instrument, apparatus, appliance, software, implant, reagent, material or other article (the main equipment) is to be used is to be ascertained from the information supplied, by the person under whose name the main equipment is or is to be supplied, on or in any one or more of the following: (a) the labelling on the main equipment; (b) the instructions for using the main equipment; (c) any advertising material relating to the main equipment; (d) any technical documentation describing the mechanism of action of the main equipment. (3) In relation to a *medical device covered by paragraph (1)(a) or (b), an accessory is a thing that the manufacturer of the thing specifically intended to be used together with the device to enable or assist the device to be used as the manufacturer of the device intended.