Navigating the MDR’s heightened surveillance and performance requirements

By Ana Quinn2022-09-16T09:25:00

Source: Adobe Stock

Substantial changes to post-market surveillance, post-market clinical follow-up and the new requirement to include a summary of safety and clinical performance, have all placed greater obligations on medical device manufacturers. The changes introduced by the Medical Device Regulation (MDR), have the overarching objective of improving patient safety and providing greater ...

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