Why this page exists
Our medical-AI guides deliberately avoid hard-coding deadlines, because the dates for AI in medical devices have been moving. This page is where those details live. The headline date is now settled: the Digital Omnibus (in force 27 July 2026) deferred AI in Annex I products to 2 August 2028. The durable part, the classification logic in Is my medical AI high-risk? (Article 6(1) and 43(3)), does not change with the calendar.
Last reviewed: 30 July 2026 (Digital Omnibus now in force).
The timeline
The row that matters most for medtech is the last one: the obligations for AI embedded in products covered by Annex I, which includes medical devices under the MDR/IVDR, phase in later than the rest of the Act, and the Digital Omnibus pushed that date from 2 August 2027 to 2 August 2028.
What the Digital Omnibus changed
The Digital Omnibus (Regulation (EU) 2026/1744) was published in the Official Journal on 24 July 2026 and entered into force on 27 July 2026. For medical devices it:
- Moved the application date for AI in Annex I products (medical devices included) to 2 August 2028 (from 2 August 2027). This is now in force.
- Confirmed medical devices stay in Annex I, Section A, so a Class IIa or higher device remains high-risk AI via the product route. There is no medical-device carve-out from the AI Act.
Separately, a broader MDR/IVDR simplification effort (aimed at reducing duplication between the AI Act and the MDR, and at narrowing when embedded AI is pulled into high-risk) is still pending in Parliament and Council. Until that lands, treat the duplication-reduction and "safety component" scope changes as not yet settled.
What this means for your planning
- Build to the logic, not the date. Whether the deadline is 2027 or 2028, the trigger (notified body → high-risk) and the integrated route (Article 43(3)) are the same. Design your conformity around those.
- Do not stall. Notified-body capacity and technical documentation take time; the extra runway is for readiness, not delay. See notified bodies and AI medical devices.
- Watch the safety-component and duplication changes. They could reduce what applies to you, which is a reason to design flexibly, not to assume the burden disappears.
For the full picture of what applies once you are in scope, see the medical-AI high-risk guide and the AI Act × MDR/IVDR crosswalk.
FAQ
When do AI Act obligations apply to medical devices?
Later than the rest of the Act. After the Digital Omnibus (in force 27 July 2026), AI in Annex I products, which includes medical devices, applies from 2 August 2028 (deferred from 2 August 2027).
Is the 2 August 2027 deadline still valid?
No. The Digital Omnibus moved it to 2 August 2028, and that deferral is now in force.
Does the Digital Omnibus reduce what applies to medical devices?
The date deferral is settled, and the Omnibus confirmed medical devices stay in Annex I, Section A. Further scope changes (narrowing the "safety component" definition, limiting AI Act requirements where the MDR/IVDR already imposes equivalent obligations) sit in a separate simplification effort that is still pending; the extent depends on the final text.
Should I wait for the dates to settle before starting?
No. The classification logic and the integrated conformity route are stable, and readiness (notified-body scope, technical documentation, data governance) takes time. Use the runway to prepare, not to delay.
Sources (official)
- EU AI Act, Regulation (EU) 2024/1689: official text on EUR-Lex; application dates in Article 113. Per-article on the European Commission AI Act Service Desk.
- Digital Omnibus, Regulation (EU) 2026/1744: published in the Official Journal 24 July 2026, in force 27 July 2026. OJ text on EUR-Lex; Council press release, 7 May 2026 (agreement stage).
Legalithm provides compliance information and tooling, not legal advice. Confirm current status with official sources and qualified counsel. Article references are to Regulation (EU) 2024/1689 (the AI Act), as amended by Regulation (EU) 2026/1744 (the Digital Omnibus).
