Explanation about the interplay between MDR and AI Act published

The "MDCG 2025-6 Interplay between the Medical Devices Regulation (MDR) and the In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)" (download PDF) was jointly developed by the Medical Devices Coordination Group (MDCG) of the European Commission, the New Technologies stakeholders group, and the EU AI Board sub-group for medical technology.

The FAQ provides a first set of answers to the most frequently asked questions related to the joint application of the AI Act and the MDR and IVDR for manufacturers of AI systems used for medical purposes. Open questions on the joint application of the sectoral and vertical legislation remain, but the Commission promised to come back with additional versions and more clarity on the interplay between the horizontal AI Act and the sectoral MDR. 

This FAQ is the first step towards a clear legislative framework for our AI medical devices and towards a more clear implementation of compliance with the two laws. It is intended to serves as a guide for stakeholders to navigate the regulatory landscape and ensure compliance with the evolving legislative framework.