MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025
This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Establishing a common understanding of these terms and concepts is necessary for the effective and harmonised implementation of the vigilance requirements under these Regulations.
Read the news announcement published by Directorate-General for Health and Food Safety on 7 January 2025.
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lsgilbert (26 février 2025). MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025. ELSIBI. Consulté le 25 avril 2025 à l’adresse https://doi.org/10.58079/13ds1