MDCG 2021-4 rev.1 – Application of transitional provisions for certification of class D in vitro diagnostic medical devices under Reg (EU) 2017/746 – September 2024
This document provides indications for how to apply the in vitro diagnostic medical devices (IVDR) provisions related to expert panels and EU reference laboratories (EURLs) before the IVDR application date, i.e. 26 May 2022, as well as around the time when the first EURL designations become applicable for the purpose of EURL tasks (1 October 2024 according to Commission Implementing Regulation (EU) 2023/2713).
Read the news announcement published by EC Directorate-General for Health and Food Safety on 25 September 2024.
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lsgilbert (5 novembre 2024). MDCG 2021-4 rev.1 – Application of transitional provisions for certification of class D in vitro diagnostic medical devices under Reg (EU) 2017/746 – September 2024. ELSIBI. Consulté le 9 décembre 2024 à l’adresse https://doi.org/10.58079/12mda