Jurisdiction(s):
European Union

Medical Device AI across the EU and UK: MDCG Guidance on EU AI Act–MDR/IVDR Interplay, High-risk Classification, Conformity, Substantial Modifications, 2027 Deadlines and UK MHRA Reform Pathways

Published on: 27 November 2025

Published by a LexisNexis EU Law expert

Legal News

Article summary

European Union Dual regulatory framework

The MDR and IVDR set out requirements addressing risks linked to medical device software; yet they do not expressly cover risks unique to AI systems. The AIA complements the MDR/IVDR by introducing obligations that target hazards and risks to health, safety, and fundamental rights that are specific to AI. This combined application obliges manufacturers to achieve compliance with both frameworks concurrently. Manufacturers of MDAI may choose, where appropriate, to incorporate the necessary testing and reporting activities, as well as the information and documentation required for their MDAI, into the documentation and procedures already established under the MDR/IVDR. In practice, alongside the MDR/IVDR and the AIA, numerous other EU regulations will often apply to these devices. With this in mind, streamlining and aligning the various processes is of paramount importance.

Quality management systems

The AIA requires providers and manufacturers to implement quality management systems (QMS) for AI systems to ensure conformity with the AIA, covering substantive requirements and procedural obligations, and applied in a proportionate manner relative to the size of the provider’s organisation. Manufacturers of AI systems may integrate the QMS elements required by the AIA within their existing QMS established under the MDR/IVDR...

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