7Kind of information—medical devices used for a special purpose that are a system or procedure pack

7 Kind of information—medical devices used for a special purpose that are a system or procedure pack

(1A) An application for a medical device used for a special purpose that is a system or procedure pack and:

(a) classified under the Regulations as a Class I medical device that:

(i) does not have a measuring function; and

(ii) the manufacturer intends to be supplied in a non-sterile state; or

(b) classified under the Regulations as a Class 1 IVD medical device; or

(c) intended by the manufacturer to be for export only;

must be accompanied by the following kind of information:

(d) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Division 1 of Part 1 of Schedule 3, which is recognised by the regulatory authority in column 2 of that item; and

(e) a conformity assessment document in relation to each medical device contained in the system or procedure pack specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

(1) An application for a medical device used for a special purpose that is a system or procedure pack, other than a medical device that is mentioned in subsection (1A), must be accompanied by the following kind of information:

(a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Division 2 of Part 1 of Schedule 3, which is recognised by the regulatory authority in column 2 of that item; and

(b) a conformity assessment document in relation to each medical device contained in the system or procedure pack specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

Additional information required where the manufacturer intends the medical device used for a special purpose to be supplied in a sterile state (2) An application for a medical device to which subsection (1) applies, and which the manufacturer intends to be supplied in a sterile state, must also be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 2 of Schedule 3, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item. (3) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (2)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (2)(b) (if any); (b) a document which accompanies the application in accordance with this section must relate to the kind of device to which the application relates.