The postponement reflects a cascade of implementation failures across the regulatory chain:
Standards not ready
CEN and CENELEC (JTC 21) missed their autumn 2025 deadline for harmonised standards under the AI Act. Delivery is now expected by end of 2026 at the earliest.
Commission guidance delayed
The Commission missed its own 2 February 2026 deadline for Article 6 guidelines on high-risk classification. No final guidance has been published as of the date of writing.
National authorities not designated
As of March 2026, only 8 of 27 Member States had fully designated their competent authorities. At least 12 missed the August 2025 deadline entirely.
Without harmonised standards, common specifications, or complete guidance, requiring compliance by August 2026 would have created a legal vacuum — providers would have obligations without knowing what compliance looks like.
The Proposed New Deadlines:
The Commission's original Digital Omnibus proposal (19 November 2025) introduced a conditional trigger: obligations would activate 6 or 12 months after the Commission confirms that adequate support measures (standards, specifications, guidelines) are available. Parliament and Council have converged on replacing this uncertain trigger with fixed calendar dates:
| Category | Original Deadline | Proposed New Deadline |
|---|
| Annex III high-risk AI systems (standalone: biometrics, critical infrastructure, education, employment, essential services, law enforcement, justice, border management) | 2 August 2026 | 2 December 2027 |
| Annex I / Article 6(1) high-risk AI systems (embedded in products regulated under EU sectoral safety legislation, including medical devices under MDR/IVDR) | 2 August 2027 | 2 August 2028 |
| AI-generated content watermarking (Article 50§2) | 2 August 2026 | 2 November 2026 (Parliament) / 2 February 2027 (Commission proposal) |
The fixed-date approach provides significantly greater legal certainty than the Commission's conditional mechanism, which left compliance timelines dependent on a future Commission decision.
Beyond Timelines- Key Substantive Amendments:
Reduced Overlap with Sectoral Legislation (Including MDR/IVDR)
MEPs argue that AI Act obligations should be less stringent for products already regulated under sector-specific EU safety laws — explicitly naming medical devices, radio equipment, and toy safety. The AI Omnibus confirms that:
- Sectoral conformity assessments (e.g., under MDR/IVDR) take precedence for high-risk AI systems embedded in regulated products.
- AI Act requirements not covered by MDR/IVDR (data governance, transparency, human oversight, robustness) can be integrated into existing sectoral conformity assessments rather than addressed through a standalone AI Act procedure.
- A single QMS can cover both device and AI Act requirements, avoiding duplication.
- Notified Bodies designated under sectoral legislation must apply for AI Act designation by 2 February 2028.
This is of direct relevance to the medical device sector, where the interplay between the AI Act and MDR/IVDR has been a source of acute uncertainty.
The Parallel DG SANTE Proposal:
It should be noted that a separate, more radical proposal from DG SANTE would exclude AI medical devices from the AI Act's high-risk framework entirely, unless later reintroduced via Commission delegated acts. This approach differs fundamentally from the Digital Omnibus (DG CONNECT), which maintains medical AI within the high-risk framework but streamlines compliance. The two proposals are still under negotiation, and their interaction remains unresolved.
What This Means in Practice:
August 2026 remains the legally binding deadline until the Omnibus is formally adopted. The legislative process — plenary vote, trilogue, formal adoption — must be completed before the original deadlines can be officially displaced.
If trilogue negotiations stall, companies could theoretically still face the original dates.
The pragmatic approach is to:
- Prepare as though August 2026 applies, but plan budgets and milestones against the December 2027 / August 2028 backstops.
- Conduct gap analyses now — particularly mapping existing MDR/IVDR or other sectoral compliance against AI Act Chapter III requirements.
- Monitor harmonised standards development (CEN-CENELEC JTC 21), especially EN 18286 (AI Quality Management System).
- Engage with Notified Bodies to understand their AI Act designation plans and capacity.
Track the DG SANTE proposal if operating in the medical device space, as it could fundamentally alter the compliance landscape for AI-enabled medical devices.
