Post-market clinical follow-up (PMCF) is an important requirement under the EU Medical Device Regulation (MDR) for continuously evaluating the safety and performance of medical devices on the market. PMCF objectives include confirming the overall safety and performance of the medical device, as well as identifying risks and systematic misuse. The design of the PMCF study must be documented in a plan, and the results are presented in a report, which is used to update the Clinical Evaluation Report (CER).
Learn more about the regulatory requirements for PMCF and practical tips for carrying out PMCF activities by joining the next BSI Clinical Masterclass:
Post-market clinical follow-up under MDR