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.