Regulation 39

is a manufacturer, an importer, a wholesaler or a registrant of a medical device;

manufactures a medical device without holding a manufacturer’s licence under section 12(1) of the Act in accordance with regulation 3;

supplies a custom‑made medical device or laboratory‑developed test that is an unregistered medical device in accordance with regulation 6;

supplies a refurbished medical device mentioned in regulation 7 as in force immediately before 1 June 2018; or

supplies an unregistered medical device in accordance with regulation 7, 8, 9, 10 or 11,must comply with the requirements in paragraph (1A).

to maintain a record of every supply by the person of the medical device; and

to produce the record mentioned in sub‑paragraph (a) for inspection by the Authority or an enforcement officer as and when the Authority or enforcement officer requires.

contains, in relation to each supply by him of the medical device, the following information:

the proprietary name or description of the medical device;

the date on which the medical device was supplied;

the name and address of the person to whom the medical device was supplied;

the quantity of the medical device supplied; and

the identification number or mark (including the control number, lot number, batch number or serial number) of the medical device supplied; and

is retained for the longer of the following periods:

the projected useful life of the medical device; or

2 years after the date on which the medical device is supplied to another person.