The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD), a more proactive approach is now required. User surveys, data collection from registries, or PMCF studies are examples of how manufacturers can collect clinical data for CE-marked devices. All planned activities are documented in the PMCF plan, including a justification of the appropriateness of each activity. But what is appropriate for what type of device? In how much detail should the results be presented in the PMCF report without duplicating the information in the clinical evaluation report (CER)? This article shares experiences and discusses some case studies for different device types.
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