For manufacturers of medical devices and in vitro diagnostics, this agreement sets an important – and challenging – course: Contrary to expectations, an exemption for AI-based medical devices was not adopted under the AI Regulation.
A. Background
Regulation (EU) 2024/1689 (AI Act) classifies certain AI systems as so-called high-risk AI systems and thereby subjects them to extensive substantive requirements (Chapter III, Section 2 of the AI Act). Medical devices containing AI components fall into this category under Article 6(1) AI Act, provided they are subject to conformity assessment by a Notified Body.
As part of the ongoing reform of the MDR/IVDR (COM (2025) 1023 final), it was planned to move medical devices from Annex I, Section A to Section B of the AI Act. This change would have resulted in the application of Article 2(2) of the AI Act, with the consequence that AI-based medical devices, despite being classified as high-risk AI systems under Article 6(1) AI Act, would no longer have been required to meet the substantive requirements under Article 8 ff. Ai Act (Chapter III, Section 2). This proposed amendment was not adopted as part of the Digital Omnibus. Such a transfer occurred only for the Machinery Regulation.
B. Consequences for Medical Devices
This decision has several consequences for medical devices.
I. Dual compliance burden remains
AI-based medical devices continue to be subject to the substantive requirements under Article 8 ff. AI Act (Chapter III, Section 2), in addition to the requirements of the MDR and IVDR.
This applies in particular to medical devices of classes IIa, IIb, and III, as well as IVDs of IVDR classes A–D, insofar as they contain AI components. Manufacturers of these devices will have to meet the following AI-specific requirements in addition to their existing MDR or IVDR obligations:
- An AI-specific risk management system that operates in parallel with ISO 14971
- Extended technical documentation in accordance with Annex IV of the AI Regulation
- Extended QMS procedures in accordance with ISO 13485
- AI-specific post-market surveillance
Although conformity assessment can be consolidated into an integrated procedure, it must be carried out by a Notified Body that is notified under both the AI Act and the MDR/IVDR.
The original problem of extensive regulatory overlap between the AI Regulation and the MDR/IVDR thus remains, for the time being, both formally and structurally. The Digital Omnibus provides that exemptions may be created in the future through implementing acts. However, until such implementing acts are adopted, it remains unclear how the conflict will be resolved. This is particularly relevant in practice because AI-based medical devices are already on the market today.
II. New Deadlines
The Digital Omnibus has postponed the effective date for high-risk AI systems under Article 6(1) AI Act —and the associated obligations—by one year: Instead of the originally planned August 2, 2027, the new effective date is August 2, 2028.
III. Registration Requirement
The agreement of 7 May 2026 on the Digital Omnibus reintroduces the obligation for providers to register high-risk AI systems in the EU database, even if they believe their system should be exempt from classification as a high-risk system.
Next steps
The provisional agreement is not yet a final binding legal act. The Digital Omnibus package must be approved and formally adopted by both the European Parliament and the Council of the EU, as well as undergo legal and linguistic review, before it can enter into force. According to the Council, this will take place in the coming weeks.
