EU AI Omnibus now in force: AI requirements for medical devices postponed to 2 August 2028
Regulation (EU) 2026/1744 entered into force on 27 July 2026 and postpones the high-risk requirements for medical devices containing AI to 2 August 2028. Notified bodies face a deadline of 28 January 2028.
Who is affected and how
- medtech company
- The compliance deadline for AI devices is 2 August 2028, so companies should also plan for the notified bodies' 28 January 2028 deadline in coordination with their certification body.
- health policy
- Medical AI counts as high-risk via the Annex I route, so preparation should build on the existing MDR certification structure.
Sources
- AI Act's Digital Omnibus is now law: AI medical devices get until 2 August 2028, but notified bodies face a 28 January 2028 deadline — QLEqle.be · Aug 3, 2026
- Digital Omnibus: New Deadlines for AI-Based Medical Devicesquickbirdmedical.com · Aug 4, 2026
- AI Act: 2028 for Devices, Article 50 Applies Nowspecculo.com · Aug 5, 2026
- EU AI Act for Medical Devices: 5 Key Obligations - Pharmadocx Consultantspharmadocx.com · Aug 3, 2026
- EU AI Act for MedTech: The Annex I Route, MDR and 2 August 2028euaiactchecklist.com · Aug 3, 2026
- EU steps up AI regulation as new transparency rules come into effectmodernghana.com · Aug 3, 2026
- EU AI Act transparency rules take effect for firmsitbrief.co.uk · Aug 4, 2026
Machine-generated summary based on the titles and excerpts of the source articles. The source article is the authority for the facts. News monitoring, not medical advice: consult a doctor for health decisions.