1、Medical Devices Joint Artificial Intelligence Board and AIB 2025-1 Medical Device Coordination Group Document MDCG 2025-6 Page 1 of 27 AIB 2025-1 MDCG 2025-6 Interplay between the Medical Devices Regulation(MDR)&In vitro Diagnostic Medical Devices Regulation(IVDR)and the Artificial Intelligence Act(

2、AIA)June 2025 This document has been endorsed by the Artificial Intelligence Board(AIB)and the Medical Device Coordination Group(MDCG)established by Article 65 of Regulation(EU)2024/1689 and Article 103 of Regulation(EU)2017/745.Both groups are composed of representatives of all Member States and ar

3、e chaired by a representative of the European Commission MDCG and a Member State(AIB).The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission.Any views expressed in this document are not legally binding and only the

4、Court of Justice of the European Union can give binding interpretations of Union law.Medical Devices Joint Artificial Intelligence Board and AIB 2025-1 Medical Device Coordination Group Document MDCG 2025-6 Page 2 of 27 Interplay between the Medical Devices Regulation(MDR)1&In vitro Diagnostic Medic

5、al Devices Regulation(IVDR)2 and the Artificial Intelligence Act(AIA)3 Introduction This document provides a first set of answers,that will be continuously developed and updated,to the most frequently asked questions related to the joint application of the AIA and the MDR or IVDR4 for manufacturers.

6、This Frequently Asked Questions(FAQ)document is primarily aimed at(but not limited to)medical device manufacturers,notified bodies and competent authorities.All references to manufacturer within the meaning of the MDR/IVDR should be understood as references to provider in accordance with the AIA.Dep