The European Commission’s Medical Device Coordination Group (MDCG) has outlined the postmarket surveillance (PMS) requirements that medical device and in vitro diagnostic makers should adhere to as ...
What is proactive PMS, and why is it necessary? The word “proactive” is used four times with respect to postmarket data collection in both the MDR and IVDR. Articles 2(60) and 2(63) respectively refer ...
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In light of the disruptions caused by the COVID 19 pandemic, the postponement of the EU MDR brought a much needed respite to an already overstrained medical devices industry that already had been ...
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