MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices

The Medical Device Coordination Group (MDCG) has published the MDCG 2023-3 guide, which aims to clarify important terms and concepts described in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR).

The guide, written for competent authorities, economic operators, and other stakeholders, provides a common understanding for an effective and harmonized implementation of the vigilance requirements under the MDR.

DOWNLOAD THE MDCG 2023-3