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MDCG 2025-5 – Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 (June 2025)

This document is intended for sponsors of performance studies of in vitro diagnostic medical devices conducted within the scope of the Regulation (EU) 2017/746. It also contains information of relevance to manufacturers providing in vitro diagnostic medical devices for use in performance studies that may be sponsored by other actors, and sponsors of combined studies.

Read the news announcement published by Directorate-General for Health and Food Safety on 18 June 2025.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (21 juillet 2025). MDCG 2025-5 – Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 (June 2025). ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/14e9n


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