Regulation 44ZL Post-market surveillance reportF1

a device placed on the market in accordance with regulation 19B and classified as belonging to class I under Directive 93/42;

a device placed on the market in accordance with regulation 19C and classified as belonging to class I under Regulation (EU) 2017/745;

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);

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;

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.

a summary of the results and conclusions of the analyses of the information collected as a result of the post-market surveillance plan, and

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.

produced within 3 years of the device being placed on the market or put into service, whichever is sooner, and

updated by the manufacturer at least every 3 years until the end of the PMS period for the device model.

the system or procedure pack incorporates a medical device which does not bear a UKCA marking or a CE marking; or

the chosen combination of medical devices is not compatible in view of their original intended use.

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;

for any other devices, the action was taken after the declaration of conformity was drawn up.