EU AI Act high-risk deadline: medical devices follow the sector-specific conformity route
According to a checklist, medical devices covered by Annex I of the AI Act follow the conformity assessment process of the underlying product's sector (19 September 2026).
Who is affected and how
- medtech company
- For devices that contain AI, the sector-specific conformity process and the high-risk deadline are part of the design.
- health IT
- It is worth requesting suppliers' declarations of conformity.
Sources
- EU AI Act High-Risk Deadline Checklist — CASRAIcasrai.org · Sep 19, 2026
- The EU AI Act makes most medical AI 'high-risk.' The hard part starts in 2027 | Health Newspapershealthnewspapers.com · Sep 19, 2026
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