Medical Device Regulatory Market Profiles
Up-to-date global regulatory summaries including health agencies, relevant regulations, device classification, and pathways to market. Select a country to get started.
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Post-market surveillance (PMS) programs in the EU are designed to monitor the performance of a marketed medical device by collecting and analyzing field use data. Post-market surveillance systems are required for all medical devices in the EU, but requirements vary based on the risk classification.
*Note - The country pages linked here and their contents are intended for reference purposes only. Use original regulations and documents when creating market submissions and making regulatory decisions. Some links provided are to non-English websites, and while browsers will translate these pages, the translations should be verified.
