EU MDR and Post Market Surveillance: What You Need to Know

January 8, 2020 / by Kapstone Medical / 5 minute read

Part 6 in a 7-part series on the EU’s Medical Device Regulation

The new EU Medical Device Regulation (MDR) builds on the framework of the MDD with an increased emphasis on post-market surveillance (PMS) and post-market clinical follow-up (PMCF), similar to FDA’s approach for high risk devices.

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