On 24 July 2026, the Official Journal published Regulation (EU) 2026/1744, the Digital Omnibus on AI, which moved the high-risk AI deadlines. The EU AI Act deadline for high-risk medical-device systems under Article 6(1) and Annex I is now 2 August 2028, prompting a review of medical AI procurement timelines. The regulation also moves the Annex III high-risk deadline to 2 December 2027.
Key Takeaways
- The amended Article 113 separates Annex I product-related high-risk AI from Annex III standalone high-risk AI, with different application dates.
- Medical-device AI reaches the Annex I route through Article 6(1), including its requirement for third-party conformity assessment.
- Prohibited-practice and GPAI model dates remain unchanged. Article 50 retains its general date, with a four-month Article 50(2) marking grace period until 2 December 2026 for systems placed on the market before 2 August 2026.
What changes under the Digital Omnibus
Regulation (EU) 2026/1744 is the Digital Omnibus on AI, published in the Official Journal on 24 July 2026. It amends Regulation (EU) 2024/1689, the AI Act. Its amendment to Article 113 changes when specified high-risk provisions apply, separating the Annex III and Annex I routes.
The amended schedule sets the application of Chapter III, Sections 1, 2 and 3, by classification route. For Article 6(2) and Annex III systems, the date is 2 December 2027. For Article 6(1) and Annex I systems, it is 2 August 2028.
A high-risk application date is the date assigned to specified obligations for a defined category of AI system. That definition matters when you review a product timeline: the date needs both a classification and an obligation attached to it. An undifferentiated reference to an AI Act extension leaves those questions unanswered.
For broader clinical context, you can read The EU AI Act and Healthcare: What Clinicians Need to Know alongside the amended schedule. Keep the legal text close when discussing which date belongs in your organization’s plans.
The revised timeline for medical-device AI
The relevant medical-device date is 2 August 2028 for systems classified under Article 6(1) and Annex I. The original Article 113 assigned that route a 2 August 2027 application date. The amended schedule gives Annex III systems a separate deadline of 2 December 2027.
The table distinguishes those changes from dates that remain in the schedule. It draws on the original Article 113, the Digital Omnibus amendment and the European Commission’s AI Act policy page.
| Category or obligation | Original application date | Date after the Digital Omnibus |
|---|---|---|
| Article 6(2), Annex III high-risk systems | 2 August 2026 | 2 December 2027 |
| Article 6(1), Annex I high-risk systems | 2 August 2027 | 2 August 2028 |
| Article 5 prohibited AI practices | 2 February 2025 | Unchanged |
| Chapter V GPAI model obligations | 2 August 2025 | Unchanged |
| Article 50 transparency obligations | 2 August 2026 | General date retained; Article 111(4) allows until 2 December 2026 for Article 50(2) marking by systems placed on the market before 2 August 2026 |
For your planning discussion, keep the Annex I and Annex III dates on separate lines. Then ask counsel or the relevant regulator which classification route supports the date proposed for your system.
How Article 6(1) applies to medical-device AI
Article 6(1) links high-risk classification to product legislation and third-party conformity assessment. It covers AI intended as a product’s safety component, or AI that is itself a product, under legislation listed in Annex I. The product must also require third-party conformity assessment under that legislation.
Annex I, Section A, includes Regulation (EU) 2017/745 on medical devices, the MDR, as item 11. It includes Regulation (EU) 2017/746 on in vitro diagnostic medical devices, the IVDR, as item 12. Those entries connect medical-device legislation to this high-risk classification route.
Annex I is the product-legislation route; Annex III is the listed-use route under Article 6(2). The phrase “medical AI” alone does not establish the conditions written into Article 6(1). Your discussion needs to address both the product relationship and the conformity-assessment requirement.
For a procurement review, frame the question around that legal mechanism: which Annex I legislation covers the product, and what assessment does it require? For a development review, request the same explanation in the classification rationale. Take any uncertainty about a particular system to counsel or the relevant regulator.
Why the deadlines moved and which obligations remain unchanged
The Digital Omnibus recitals explain the deferral through implementation difficulties. Recital 40 cites delayed standards, common specifications and alternative guidance, alongside delayed establishment of national competent authorities. The regulation also identifies increased implementation costs as a reason the original application dates were no longer justified.
That explanation concerns the conditions for implementation. It should be read alongside the specific dates and categories in amended Article 113. When discussing the extension, distinguish the reason for the change from the provisions whose application dates changed.
Article 5, titled “Prohibited AI practices,” sits in Chapter II and applied from 2 February 2025. Chapter V contains the general-purpose AI model obligations, applicable from 2 August 2025. The European Commission’s policy page confirms those earlier application dates alongside the revised high-risk schedule.
Article 50 sits in Chapter IV and follows the general 2 August 2026 application date. Its transparency provisions address informing people about AI interaction, marking synthetic content, and disclosures involving emotion recognition or biometric categorisation. However, new Article 111(4) gives systems placed on the market before 2 August 2026 until 2 December 2026 to meet the Article 50(2) marking duty.
For synthetic audio, images, video or text, Article 50(2) addresses machine-readable marking and detectability as artificially generated or manipulated. Keep that provision distinct from the Annex I deadline when raising transparency questions with your advisers.
Questions to resolve before revising a clinical AI plan
Begin your review with the system’s classification and the specific obligation under discussion. The amended timetable distinguishes product-related high-risk systems, Annex III systems and provisions with unchanged dates. A useful planning note would identify the relevant article, classification route and application date together.
In a supplier discussion, request the basis for an Annex I or Annex III classification before accepting a revised milestone. With your regulatory team, separate questions about high-risk provisions from questions about prohibited practices, GPAI models and transparency. Treat these as questions for assessment, rather than a ready-made compliance conclusion.
You can pair that discussion with Clinical Decision Support in 2026: What AI Can and Cannot Do when reviewing a clinical tool. Bring the proposed timeline and its classification rationale to counsel or the relevant regulator for your own case.
Frequently Asked Questions
Did the EU AI Act deadline for medical AI move?
Yes. Regulation (EU) 2026/1744 moves the Article 6(1) and Annex I high-risk deadline from 2 August 2027 to 2 August 2028. The separate Annex III high-risk deadline moves from 2 August 2026 to 2 December 2027.
Does this mean all AI rules for medical devices wait until 2028?
No. The 2 August 2028 date concerns the Article 6(1) and Annex I high-risk route. Prohibited-practice and GPAI model dates are unchanged. Article 50 generally applies from 2 August 2026, but Article 111(4) gives systems placed on the market before that date until 2 December 2026 for Article 50(2) marking.
Which AI Act application dates were left unchanged?
Prohibited AI practices under Article 5 applied from 2 February 2025, and Chapter V GPAI model obligations applied from 2 August 2025. Article 50 retains its general 2 August 2026 date, with Article 50(2) marking deferred until 2 December 2026 for systems placed on the market before 2 August 2026.
Why did the EU delay the high-risk deadlines?
The regulation’s recitals cite delays in standards, common specifications, guidance and the establishment of national competent authorities. They also identify implementation costs that no longer justified maintaining the original application dates.
Sources
- Regulation (EU) 2026/1744, Digital Omnibus on AI, Official Journal of the European Union, 24 July 2026.
- Regulation (EU) 2024/1689, original AI Act text, Official Journal of the European Union, 2024.
- AI Act policy page, European Commission, accessed 27 September 2026.
This article is for general information and is not legal, regulatory or medical advice.