医疗器械法规（MDR）与体外诊断医疗器械法规（IVDR）及人工智能法案（AIA）之间的相互作用

Joint Artificial Intelligence Board andMedical Device Coordination Group Document AIB2025-1 MDCG 2025-6Interplay between the MedicalDevicesRegulation (MDR) & In vitro DiagnosticMedical Devices Regulation (IVDR) andthe Artificial Intelligence Act (AIA) June2025 This document has been endorsed by theArtificial Intelligence Board (AIB)and theMedical Device Coordination Group (MDCG) established byArticle65of Regulation(EU)2024/1689 and Article 103 of Regulation (EU) 2017/745.Both groups arecomposedof representatives of all Member States and are chaired by arepresentative of the European CommissionMDCG and a Member State (AIB). The document is not a European Commission documentand it cannot be regardedas reflecting the official position of the European Commission. Any views expressedin this document are not legally binding and only the Court of Justice of the EuropeanUnion can give binding interpretations of Union law. Interplay between the Medical Devices Regulation(MDR)1&In vitroDiagnostic Medical DevicesRegulation (IVDR)2and the Artificial Intelligence Act(AIA)3 Introduction This document provides a first set of answers, that will be continuouslydevelopedand updated, to the most frequently asked questions related to the joint application ofthe AIA and the MDR or IVDR4for manufacturers. This Frequently Asked Questions(FAQ)document is primarily aimed at(but not limited to)medical devicemanufacturers,notified bodies and competent authorities.All references to‘manufacturer’within the meaning of the MDR/IVDR should be understood asreferences to ‘provider’ in accordance with the AIA.‘Deployer’ defined in the Article3(4) AIA as a natural or legal person, public authority, agency or other body using AIsystems under their authority, unless the use is for a personal non-professionalactivity.The AIA does not define the concept of ‘user’ which is defined in theMDR/IVDRas any healthcare professional or lay person who uses a device.Therefore, the concept of ‘deployer’ under AIA cannot be understood as referring to‘user’ under MDR/IVDR. The MDRandIVDR requirements address risks related to medical device software,however,they do not explicitly address risks specific to AI systems.The AIAcomplements the MDR/IVDR by introducing requirements to address hazards andrisks for health, safety and fundamental rights specific to AI systems. In line with theNewLegislativeFrameworkapproach,thismeansasimultaneousandcomplementary application of the MDR/IVDR and the AIA for medical devices thatcontains one or more high-risk AI system. For the purposes of this document, AI systems used for medical purposes arereferred to as Medical Device Artificial Intelligence(MDAI).All references toMDAIshall be understood to also cover MDR Annex XVI products, accessories to medicaldevices, in vitro diagnostic medical devices and accessories to in vitro diagnosticmedical devices. Medical Devices Joint Artificial Intelligence Board andMedical Device Coordination Group Document The guidance provided in this document is without prejudice to the guidance that theEuropean Commission may adopt on the basis of the AIA. In order to ensure consistency, avoid duplication and minimise additional burdens,manufacturers of MDAI, in accordance with paragraph 2 of Article 8 of the AIA, haveachoice ofintegrating,as appropriate,the necessary testing and reportingprocesses, information and documentation they provide with regard to their MDAI intodocumentationand procedures that already established under the MDR/IVDR.Manufacturers of MDAI, are strongly encouraged to use this flexibility provided inparagraph 2 Article 8 of the AIA. In applying this flexibility, MDAI manufacturers,however, shall ensure that MDAI are fully compliant with all applicable requirementsof the AIA, MDR or IVDR and any other applicable Union legislation. Medical Devices Contents I.Scope of application and classification..............................................5II.Requirements....................................................................................71.Management Systems...................................................................72.Data Governance...........................................................................93.Technical Documentation.............................................................124.Transparency and human oversight.............................................135.Accuracy, Robustness and Cybersecurity....................................18III.Clinical /Performance Evaluation and Testing..............................20IV.Conformity assessment................................................................22V.Substantial Modification/significant change.....................................23VI.Post-market monitoring................................................................25VII.Other questions............................................................................26 Medical Devices I.Scope of application and classification 1.When