What is post-market surveillance for medical devices

1. What is post-market surveillance for medical devices? Post-market surveillance is a vital part of the EU Medical Device and IVD regulation, All activities are carried out by manufacturers in cooperation with other economic operators to institute and maintain a systematic procedure to proactively collect and review experience gained from devices they place on the market, and make available on the market. All medical device manufacturers must have a documented system in place that: Captures and reports on all adverse events related to their devices Proactively generates and stores feedback about these devices To do this effectively, the regulation requires companies to Document their PMS plans Produce required reports based on those plans Make them available to the regulator during audits Manufacturers should base their PMCF process on a PMCF plan. The findings of the PMCF must be documented in a PMCF evaluation report which, in turn, will form part of a Clinical Evaluation Report (CER) and the technical documentation.