AI Compass / News
AI Act for medical devices delayed to August 2028: more time, same work
The Digital Omnibus pushes the high-risk obligations for AI in medical devices back by a year. Notified bodies warn of a bottleneck.
Source: Regulation (EU) 2026/1744 (Digital Omnibus on AI), Official Journal of the EU,
Note: I provide engineering services in regulatory affairs for medical devices.
What happened: Under Regulation (EU) 2026/1744, the “Digital Omnibus on AI”, the high-risk obligations of the EU AI Act for AI in regulated products apply only from 2 August 2028. That includes medical devices and in vitro diagnostics. The regulation was published in the Official Journal on 24 July 2026 and entered into force on 27 July. Many older articles still give August 2026 or August 2027. Those dates are out of date.
The problem: The delay is only one year, and the obligations themselves are essentially unchanged. The MDR and IVDR remain listed in Annex I Section A of the AI Act, so the AI requirements still apply on top of medical device regulation. Team-NB, the European association of medical device notified bodies, warns that designating notified bodies under the AI Act can only start once the implementing acts are in place, possibly in early 2027 if legislators act swiftly. That leaves less than two years for designation and conformity assessment. Team-NB expects bottlenecks and capacity problems.
What manufacturers can do:
- One file, not two: Extend the MDR technical documentation (Annexes II and III) to cover the AI Act topics: data governance, logging, human oversight, and accuracy and robustness. Conformity assessment remains a single procedure under Article 43(3) of the AI Act. How the MDR and the AI Act interact is set out in the guidance document MDCG 2025-6.
- Run a gap analysis now: Check the existing technical file against the AI Act requirements and prioritise the open points.
- Document training data properly: The origin, selection and preparation of data are hard to reconstruct after the fact, so this work pays off early.
- Talk to your notified body early: Anyone who waits until 2028 will probably find themselves in a queue.
Context: The Omnibus also requires the Commission to adopt delegated acts by 2 August 2027 specifying which AI Act obligations may be limited for products under Annex I Section A, where that product legislation already provides equivalent protection and the overall level of protection is not reduced. Whether the MDR and IVDR will be covered is open. Don’t count on it in your planning yet.
Addendum 27 October 2026: Under current law the MDR and IVDR are in Section A, but the Commission wants to move them: its proposal COM(2025) 1023 of 16 December 2025 to reform the MDR and IVDR puts both in Section B. For AI medical devices, only the AI Act provisions referred to in its Article 2(2) would then apply, and the Commission could lay down specific AI requirements by implementing or delegated act. None of this has been adopted: according to Parliament’s Legislative Observatory, the file is still awaiting a decision by the public health committee, and the TÜV association, whose member organisations include notified bodies for medical devices, warned against this “sector exit” on 30 September 2026. Until there is a decision, keep planning for the full AI Act obligations.
What does this mean for your team? Let’s talk it through. Request an intro call