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Revision 2 of MDCG 2022-4 on MDR Appropriate surveillance

This guidance document outlines the activities to be performed by notified bodies12 as part of the appropriate surveillance defined in Article 120(3e) MDR. In order to clarify elements to be verified by notified bodies, this guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect to their quality management system.

Read the news announcement published by EC Directorate-General for Health and Food Safety on 27 May 2024.

 


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (5 juillet 2024). Revision 2 of MDCG 2022-4 on MDR Appropriate surveillance. ELSIBI. Consulté le 18 mars 2025 à l’adresse https://doi.org/10.58079/11yax


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