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MDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025)

This document provides a first set of answers to the most frequently asked questions related to the joint application of the Artificial Intelligence Act and the Medical Devices Regulation or In vitro Diagnostic Medical Devices Regulation for manufacturers. This Frequently Asked Questions document is primarily aimed at (but not limited to) medical device manufacturers, notified bodies and competent authorities.

Read the news announcement published by Directorate-General for Health and Food Safety on 19 June 2025.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (21 juillet 2025). MDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025). ELSIBI. Consulté le 13 janvier 2026 à l’adresse https://doi.org/10.58079/14e9m


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