reg 44ZM Periodic safety update report
(1) Subject to paragraph (4), unless regulation 44ZL (post-market surveillance report) applies to the device, the manufacturer must produce a periodic safety update report (“ PSUR ”) for each device placed on the market or put into service. (2) The manufacturer may prepare a single PSUR for a category or group of devices if— (a) the devices are covered by the same clinical evaluation report under Regulation (EU) 2017/745 or performance evaluation report under Regulation (EU) 2017/746 , or (b) the devices are similar devices and the manufacturer considers that the similarity between the devices justifies preparing a single PSUR for those devices. (3) The PSUR must include— (a) a summary of the results and conclusions of the analyses of the information collected as a result of the post-market surveillance plan; (b) a description of any preventive or corrective action that has been taken by the manufacturer in relation to the device and the reason for doing so; (c) the required risk analysis; (d) the conclusions of any post-market clinical follow-up required under Part 2 or 3; (e) the number of— (i) devices placed on the market in the UK; and (ii) devices put into service in the UK without being placed on the market; (f) a description of the characteristics of the population using the device; (g) an estimate of— (i) the size of the population using the device in the UK; (ii) the size of the population using the device outside the UK; (iii) the usage frequency of the device, where it is practicable to make such an estimate. (4) This regulation shall not apply to a relevant device which is a system or procedure pack, unless— (a) the system or procedure pack incorporates a medical device which does not bear a UKCA marking or a CE marking; or (b) the chosen combination of medical devices is not compatible in view of their original intended use. (5) In paragraph (3)(b), “ any preventive or corrective action ” includes any action taken before the device was placed on the market or put into service, if that action was taken after an approved body or notified body issued a certificate in respect of the device. (6) Unless paragraph (7) applies, the manufacturer must— (a) produce the first PSUR within 1 year of the device being placed on the market or put into service, whichever is sooner, and (b) update the PSUR at least every year until the end of the PMS period for the device model. (7) This paragraph applies to— (a) a device placed on the market in accordance with regulation 19B and classified as belonging to class IIa under Directive 93/42; (b) a device placed on the market in accordance with regulation 19C and classified as belonging to class IIa under Regulation (EU) 2017/745 ; (c) a device otherwise placed on the market or put into service in accordance with Part 2 and classified as belonging to class IIa under regulation 7 (classification of general medical devices). (8) Where paragraph (7) applies, the manufacturer must— (a) produce the first PSUR within 2 years of the device being placed on the market or put into service, whichever is sooner, and (b) update the PSUR at least every 2 years until the end of the PMS period for the device model. (9) The manufacturer must submit the PSUR and each updated PSUR to the approved body for the device (if there is one). (10) The approved body must take into account the PSUR and updated PSURs when carrying out its surveillance activities as part of a conformity assessment procedure set out in these Regulations. (11) In respect of a device listed in paragraph (12), the approved body must, as soon as reasonably practicable following receipt— (a) review the PSUR and each updated PSUR to determine whether there is any impact on the certification issued for the device, and (b) issue a report to the manufacturer and the UK responsible person (if there is one), setting out the conclusions of that review. (12) The devices referred to in paragraph (11) are— (a) a device placed on the market or put into service in accordance with Part 2 and classified as belonging to class III under regulation 7 (classification of general medical devices); (b) a device placed on the market or put into service in accordance with Part 2 and considered to be an implantable device under Directive 93/42; (c) a device placed on the market or put into service in accordance with Part 3; (d) a device placed on the market or put into service in accordance with Part 4 that is referred to in the lists in Annex II of Directive 98/79. (13) The approved body must provide a copy of its completed reports under paragraph (11) to the Secretary of State upon request and within 3 working days of the date of any such request.