Regulation 39A

maintain a record relating to every receipt (where applicable) and every supply by the person of the medical device; and

produce such record for inspection by the Authority or an enforcement officer as and when required by the Authority or enforcement officer.

contains, in relation to (where applicable) each receipt, and each supply, by the person of the medical device, all of the following information:

the proprietary name or description of the medical device;

the date on which the medical device was received and supplied;

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

the quantity of the medical device received and supplied; and

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

is retained for the following periods:

for any registered medical device used in a regulated clinical trial or any medical device used in any clinical research that is not a regulated clinical trial, the longer of the following periods:

the projected useful life of the medical device;

2 years after the date on which the medical device is supplied;

for any unregistered medical device used in a regulated clinical trial, the period for which records must be kept under regulation 23(2)(c) of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016) or regulation 23(2)(c) of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016), as the case may be.