Michael EngelEngineering services (RA & AI)

AI Act for medical devices delayed to August 2028: more time, same work

Area 9: Regulatory affairs & medical devices

Disclosure: The operator of this site provides 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 Those dates are out of date.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 association of notified bodies, warns that designating notified bodies under the AI Act can only start once the implementing acts are in place, expected in early 2027. That leaves less than two years for designation and conformity assessment. Team-NB expects bottlenecks and capacity problems.

What manufacturers can do:

  1. 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.
  2. Run a gap analysis now: Check the existing technical file against the AI Act requirements and prioritise the open points.
  3. Document training data properly: The origin, selection and preparation of data are hard to reconstruct after the fact, so this work pays off early.
  4. Talk to your notified body early: Anyone who waits until 2028 will probably find themselves in a queue.

Context: The Omnibus also allows the Commission to limit individual AI Act obligations by delegated act where product legislation already provides equivalent protection. Whether and when that will happen for the MDR and IVDR is open. Plans should not rely on it yet.

Source: Regulation (EU) 2026/1744 (Digital Omnibus on AI), Official Journal of the EU, of 24 Jul 2026