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 ...
From May 26, 2020 onwards, medical device manufacturers operating and/or selling within the European Union must comply with the Medical Device Regulation (EU 2017/745), or “EU MDR”. This regulation’s ...
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