AI Act for Medical Devices: Deadlines & Omnibus Tracker

Why this page exists

Our medical-AI guides deliberately avoid hard-coding deadlines, because the dates for AI in medical devices are moving. This page is where those volatile details live. Treat everything here as provisional and check the status column. 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: 9 July 2026.

The timeline (provisional)

The row that matters most for medtech is the last two: 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 would push that date out further.

What the Digital Omnibus changes

The Digital Omnibus was presented by the European Commission on 19 November 2025, and a provisional agreement between the Council and Parliament followed in 2026. For medical devices it would, per the Council:

• Move the application date for AI in Annex I products (medical devices included) to 2 August 2028.
• Narrow the "safety component" definition, so AI used purely for non-safety functions is less likely to be pulled into high-risk by virtue of being embedded in a regulated product.
• Empower the Commission to limit AI Act requirements where the MDR/IVDR already imposes equivalent obligations, reducing duplication.

Some proposals go further on where medical devices sit within Annex I, which would affect how many AI Act requirements apply directly. Until the package is finally adopted, the exact dates and scope are not 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.

When do AI Act obligations apply to medical devices?

Later than the rest of the Act. The original date for AI in Annex I products (which includes medical devices) was 2 August 2027, and the Digital Omnibus proposes moving it to 2 August 2028. Treat the exact date as provisional until the package is finally adopted.

Is the 2 August 2027 deadline still valid?

It is being moved. The Digital Omnibus proposes 2 August 2028 for AI in Annex I products. Because the package is not yet final, plan to the classification logic and track the date here.

Does the Digital Omnibus reduce what applies to medical devices?

Possibly. It would narrow the "safety component" definition and let the Commission limit AI Act requirements where the MDR/IVDR already imposes equivalent obligations. 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, European Commission proposal of 19 November 2025; Council and Parliament provisional agreement: Council press release, 7 May 2026. Provisional and not yet final.

Legalithm provides compliance information and tooling, not legal advice. Dates and scope are provisional and change; confirm current status with official sources and qualified counsel. Article references are to Regulation (EU) 2024/1689 (the AI Act).