Regulation 39B

maintain a record of the putting to some other use, disposal or export of a medical device under that provision; and

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

contains all of the following information in relation to each medical device which is put to some other use, disposed of or exported:

the proprietary name or description of the medical device;

the date on which the medical device was put to the other use, disposed of or exported;

the name and address of the person responsible for the putting to the other use, disposal or export, of the medical device;

the quantity of the medical device put to the other use, disposed of or exported;

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

is retained —

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, for 2 years after the time when the medical device is put to some other use, is disposed of or is exported, as the case may be; or

for any unregistered medical device used in a regulated clinical trial, for 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.