Regulation 41

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 complaint received by the person pertaining to 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 the following information:

the proprietary name or description of the medical device that is the subject of the complaint;

the date on which the complaint was received;

the name and address of the complainant or, if unavailable, a unique identifier for the complaint;

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

the nature of the problem that is the subject of the complaint; and

is retained for at least 5 years after the expiry of the projected useful life of the medical device.