Date13.07.2021 | 16:00 - 16:45
Locationonline

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Clinical evidence – Part 1: Performance evaluation

Regulation (EU) 2017/746 (IVDR) sets high requirements on clinical evidence, including the demonstration of scientific validity, analytical performance and clinical performance for all in vitro diagnostics devices. In the first part of this Keynote series, we discuss the process of performance evaluation throughout the life cycle of de IVD devices. You get an overview on how to perform a gap analysis for clinical evidence, identify the available clinical data sources and plan new activities to cover the IVDR requirements on post-market performance follow-up (PMPF).

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