reg 44ZL Post-market surveillance report
(1) Subject to paragraph (4), the manufacturer must produce a post-market surveillance report (“ PMSR ”) for the following— (a) a device placed on the market in accordance with regulation 19B and classified as belonging to class I under Directive 93/42; (b) a device placed on the market in accordance with regulation 19C and classified as belonging to class I 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 I under regulation 7 (classification of general medical devices); (d) a device placed on the market in accordance with regulation 44ZB and classified as belonging to class A or B under Regulation (EU) 2017/746 ; (e) a device otherwise placed on the market or put into service in accordance with Part 4 that is not a device referred to in the lists in Annex II of Directive 98/79. (2) The PMSR 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, and (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. (3) A PMSR must be— (a) produced within 3 years of the device being placed on the market or put into service, whichever is sooner, and (b) updated by the manufacturer at least every 3 years until the end of the PMS period for the device model. (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 (2)(b) the reference to “ any preventive or corrective action ” includes any action taken before the device was placed on the market or put into service if— (a) for devices with a certificate that was issued by an approved body or notified body before the declaration of conformity was drawn up, the action was taken after that certificate was issued; (b) for any other devices, the action was taken after the declaration of conformity was drawn up.