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MDCG 2022-20 – Substantial modification of performance study under Regulation (EU) 2017/746 – December 2022

In the absence of the European database on medical devices (EUDAMED), a series of performance study application/notification documents have been created to support performance study procedures with respect to the in vitro diagnostic medical devices. To add to these documents, a template for ‘Substantial modification of performance study under Regulation (EU) 2017/746 is also provided.

Read the news announcement published by EC Directorate-General for Health and Food Safety on 14 December 2022.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (24 janvier 2023). MDCG 2022-20 – Substantial modification of performance study under Regulation (EU) 2017/746 – December 2022. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o66b


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