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MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies – December 2023

The guidance document provides elements useful for the qualification of a product as a product without an intended medical purpose listed in Annex XVI to the Medical Device Regulation. It also provides explanations and examples for the application of certain classification rules to products without an intended medical purpose.

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 2023-5 – Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies – December 2023. ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/vtoa


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