FAQ-style guidance issued jointly by the Medical Device Coordination Group (MDCG) and the Artificial Intelligence Board (AIB 2025-1 / MDCG 2025-6, June 2025) on the interplay between the MDR, the IVDR and the EU Artificial Intelligence Act (AIA), addressed primarily to manufacturers, notified bodies and competent authorities. It is not legally binding. Medical device AI (MDAI) is high-risk under the AIA where it is a safety component of a device, or is itself a device, and is subject to third-party conformity assessment by a notified body. The document explains how AI-specific requirements, such as data governance with attention to bias, transparency, human oversight, and accuracy, robustness and cybersecurity, can be integrated into a single set of MDR/IVDR technical documentation and the conformity assessment. It also covers post-market monitoring and pre-determined changes for MDAI that continue to learn after being placed on the market, noting that guidance on pre-determined change control plans was still under development. The AIA high-risk application date cited in the document (2 August 2027) reflects the law at the time of issue; under Regulation (EU) 2026/1744 it is now 2 August 2028 for Annex I products, which include medical devices.

Guidance (MDCG 2025-4, published 16 June 2025) clarifying the responsibilities of online platforms that make medical device software (MDSW) apps available, and how the MDR, the IVDR, and the Digital Services Act (DSA) interact. Where a platform merely connects a manufacturer with users, it is treated as an online marketplace under the DSA rather than a distributor or importer under the MDR/IVDR, but it still carries DSA obligations such as a mechanism for reporting illegal content, ensuring manufacturers provide transparent safety and compliance information, and, for very large platforms, risk assessment and mitigation. Where a platform itself supplies the app directly to users, it is instead treated as a distributor or importer under the MDR/IVDR, the DSA no longer applies, and the platform must verify compliance and cooperate with authorities. The guidance also recommends that platforms create a dedicated category for MDSW apps, separate from general health and wellness apps, and lists the information manufacturers should provide, including the device name, manufacturer details (including the Single Registration Number, SRN), the MD or IVD symbol, intended purpose, warnings, a link to the electronic instructions for use (eIFU), and the UDI-DI.

Revision 1 of MDCG 2019-11 (published 17 June 2025), the core guidance on qualifying software as a medical device (MDSW) and classifying it under the MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746). The revision clarifies the scope of the guidance, adds considerations on establishing a clear intended purpose and on modular MDSW (defining intended purpose at the level of individual functional modules), and clarifies the interpretation of Classification Rule 11 sub-rule (a) concerning devices intended to prevent the risk of illness, with additional reference material and examples. It also adds a new Class I example to Annex IV and updates Annex I to reflect the interplay with the European Health Data Space Regulation.