Update – MDCG 2022-9 rev.1 – Summary of safety and performance template – April 2024
Regulation (EU) 2017/746 on in vitro diagnostic medical devices requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body and made available to the public via the European database on medical devices (Eudamed).
Read the news announcement published by EC Directorate-General for Health and Food Safety on 15 April 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (21 mai 2024). Update – MDCG 2022-9 rev.1 – Summary of safety and performance template – April 2024. ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/11p04
