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) that moves closer to the FDA’s approach.
The FDA defines PMS as the process of “active, systematic, scientifically valid collection, analysis and interpretation of data and other information about a marketed device.”
