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.
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