The requirements for Post-Market Clinical Follow-up (PMCF) as part of Post-Market Surveillance (PMS) under the MDR are well-known and most medical device manufacturers have robust procedures in place.
However, selecting the right PMCF activity for a medical device, considering the available clinical evidence, device classification and market history, remains a challenge. User surveys are often associated with low response rates, PMCF studies are sometimes conducted with inappropriate endpoints, and registries might provide incomplete information.
Therefore, it is crucial to identify the most suitable PMCF method right away to save time and costs.
The workshop will briefly review the PMCF requirements under the EU MDR 2017/745 and will then dive into different methods to collect clinical data in the post-market phase.
This includes user surveys, different designs for PMCF studies, registries, or electronic health records.
Participants will have the chance to work on several case studies to learn how to select the ideal PMCF activity for medical devices with different requirements regarding the expected clinical evidence.