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MDCG 2023-6 – Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies – December 2023

The MDCG guidance covers the demonstration of equivalence, based on data pertaining to an already existing device, for the purpose of CE-marking under the Medical Device Regulation (MDR) and is applicable to products without an intended medical purpose listed in the Annex XVI of MDR and covered by the common specifications.

Read the news announcement published by EC Directorate-General for Health and Food Safety on 14 December 2023.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (13 février 2024). MDCG 2023-6 – Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies – December 2023. ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/vto9


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