Key takeaway
AI medical devices that need a notified body become high-risk under the EU AI Act from 2 August 2028, and the 2026 Digital Omnibus kept them fully in scope. What changes on top of the MDR, and how to prepare.
Short answer: From 2 August 2028 for most AI medical devices. Under the AI Act, an AI system that is a medical device, or a safety component of one, is high-risk when the device needs a notified body under the MDR or IVDR. That covers Class IIa, IIb and III devices and most IVDs. The Digital Omnibus, in force since July 2026, moved this deadline from August 2027 but kept medical devices fully in scope. Manufacturers will need one technical file that meets both the MDR and the AI Act.
The test is in Article 6(1) of the AI Act. Two conditions must both apply: the AI system is a medical device, or a safety component of one, and the device needs third-party conformity assessment by a notified body under the MDR or IVDR.
Being high-risk under the AI Act does not raise a device's MDR class. It adds requirements on top.
The original timetable would have applied high-risk rules to medical devices from 2 August 2027. EU institutions reached a political agreement on the Digital Omnibus on AI on 7 May 2026. The final text, Regulation (EU) 2026/1744 of 8 July 2026, was published in the Official Journal on 24 July 2026 and applies from 27 July 2026. The key dates now are:
Sources: Regulation (EU) 2026/1744, via Cuatrecasas (July 2026) and Gibson Dunn (May 2026).
The bigger fight was over scope. In December 2025, the Commission's proposal to simplify the MDR and IVDR (COM(2025) 1023) would have moved medical devices to Annex I Section B of the AI Act, where most high-risk requirements do not apply. Parliament and Council rejected that move in May 2026. As a compromise, the Commission can use implementing acts to limit specific AI Act requirements where the MDR or IVDR already give an equivalent level of protection (Gleiss Lutz).
Industry was not pleased. "This is not the outcome MedTech Europe sought," the trade association said, calling the MDR and IVDR revision "the critical vehicle" for avoiding duplicate requirements (MedTech Europe, May 2026).
At MedTech Meets AI 2025 in Barcelona, Luca Neri, Vice President and Product Center Manager of Applied AI & GenAI at the Renal Research Institute, Fresenius Medical Care, summed up the relationship between the two laws in the regulation part of his presentation:
"AI Act & MDR: two uneven siblings."
Luca Neri, MedTech Meets AI, Barcelona, 2025
The MDR asks about safety, performance and clinical benefit. The AI Act adds data governance, logs, transparency and human oversight. Neri also pointed out that EU health technology assessment evidence requirements do not line up with either, so manufacturers can end up writing several dossiers for the same product.
He showed what that costs. A MedTech Europe survey he cited put CE-marking at 18 to 22 months, and found that the share of manufacturers choosing the EU as their first launch market fell by 40% for IVDs and 33% for medical devices. Yet his team's Anemia Control Model, a CE-marked neural network trained on more than 900,000 prescriptions, shows the payoff: published studies link it to 18% higher target achievement and fewer hospitalisations.
According to MDCG 2025-6, the guidance on the interplay between the MDR, IVDR and AI Act published in June 2025, high-risk AI medical devices must also show:
The good news is that it runs through one process. The same notified body, if designated under both laws, assesses one technical file.
The tools for compliance are also arriving. In October 2026, EN 18286:2026, a quality management standard written for the AI Act, became the first harmonised standard referenced in the Official Journal, through Implementing Decision (EU) 2026/2274. Building an AI quality system on it gives a presumption of conformity with the AI Act's quality management article (CEN-CENELEC JTC 21).
Header photo: Umanoide on Unsplash.
Yes. AI systems that are medical devices, or safety components of them, are high-risk under the AI Act when the device needs notified-body assessment under the MDR or IVDR. The high-risk requirements apply to these devices from 2 August 2028.
Usually not. Most Class I devices are self-certified, so they fall outside the Article 6(1) route. Class I devices that are sterile, have a measuring function or are reusable surgical instruments need a notified body and are high-risk.
Not for now. The Commission proposed in December 2025 to move medical devices to a lighter part of the AI Act, but Parliament and Council rejected this in May 2026. The Commission can still limit specific requirements by implementing act where the MDR or IVDR give equivalent protection.
It is guidance from the Medical Device Coordination Group, published in June 2025, explaining how the MDR, IVDR and AI Act work together. It recommends one technical file and one conformity assessment for high-risk AI medical devices.
No. One conformity assessment, normally by the same notified body, covers both the device regulation and the AI Act, and the device carries one CE mark.
MedTech Meets AI, organised by UBIQ Events in Barcelona, brings together leaders from top MedTech companies to discuss AI regulation, imaging and diagnostics, and clinical adoption.
