When do the AI Act deadlines hit medical devices?

In short: Under the Digital Omnibus package — published in the Official Journal on 24 July 2026 and in force from 27 July 2026 — Annex III general high-risk obligations move to 2 December 2027 and Article 6(1) medical-device obligations to 2 August 2028, roughly 16 months and a full year later than the Act's original dates. From entry into force, the deferred dates are the legally binding ones; the original dates (2 August 2026 and 2 August 2027) are superseded. Article 4 AI literacy has applied since 2 February 2025 already, regardless of the Omnibus, with no grace period.

Status (updated 25 July 2026): Official Journal publication is confirmed — the deferred dates are the legally binding ones from 27 July 2026. Next scheduled review: 1 October 2026.

What actually changed, and when

The Digital Omnibus package that postpones the AI Act's (Regulation (EU) 2024/1689) high-risk deadlines was published in the Official Journal on 24 July 2026 as Regulation (EU) 2026/1744 and enters into force on 27 July 2026. From entry into force, the deferred dates are the legally binding ones: 2 December 2027 for the general Annex III high-risk route — the broad "if your AI system is a listed high-risk use case" route — and 2 August 2028 for the Annex I route that catches most medical device AI, via Article 6(1) automatic high-risk status for AI that's part of a Notified-Body-assessed device. The original dates (2 August 2026 for Annex III; 2 August 2027 for Article 6(1)) are superseded. Plan against the deferred dates.

The one date that hasn't moved, and never will by Omnibus

Article 4, the AI literacy obligation requiring providers and deployers to ensure staff have sufficient AI literacy for their role, is not part of the deferred timeline at all — it has been in force since 2 February 2025, with no transitional arrangement. If you've been treating Article 4 as a future deadline, that's the single most important correction on this page: it's a live obligation today, not something to schedule for later — though note the Act attaches no dedicated fines regime to Article 4 itself. Also already in force and untouched by the Omnibus: the Act's prohibited-practices ban (since 2 February 2025) and the general-purpose AI obligations (since 2 August 2025); Article 50 transparency obligations remain on 2 August 2026, unmoved.

What this means for your planning

The deferral is genuine additional runway for the Article 6(1) medical-device work specifically, but it isn't a reason to stop building — the underlying data-governance, logging, and human-oversight documentation is most efficiently built into your MDR technical file as you go, not assembled in a rush closer to 2028. Treat this page as a living document: we revise it on any further material development, or by 1 October 2026 at the latest, whichever comes first — re-check before planning against it if you're reading this after that date.

Where next: AI Act Dates After the Digital Omnibus · What is the AI literacy obligation (Article 4)?

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