FAQ-style guidance jointly issued by the Medical Device Coordination Group (MDCG) and the AI Board (MDCG 2025-6 / AIB 2025-1, published 19 June 2025) on the interplay between the Medical Devices Regulation (MDR), the In Vitro Diagnostic Medical Devices Regulation (IVDR), and the EU Artificial Intelligence Act (AIA). Addressed to manufacturers, competent authorities, and notified bodies, it explains how AI-specific requirements, such as data governance, algorithmic transparency, performance monitoring, bias mitigation, and human oversight, can be integrated into existing MDR/IVDR technical documentation and a single conformity assessment rather than requiring separate processes. It also touches on post-market surveillance obligations and the use of predetermined change control plans (PCCPs), relevant ahead of the AI Act obligations that are expected to start applying from August 2027.

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.