WHITEPAPER BSI / ECLEVAR EU MDR – POST-MARKET CLINICAL FOLLOW-UP: Gaining Real-world Evidence

November 7, 2023

The purpose of this document is to guide the medical device manufacturer in the implementation of real-world data collection as part of Post-Market Clinical Follow-up (PMCF) with a view to the submission of that data for evaluation by the notified body. It aims to explain the challenges, and provide practical solutions, relating to methodological aspects to optimize the level of evidence provided by these activities and confidence in their results.

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