EU AI Act in healthcare: high-risk rules and deadlines in 2027 and 2028
Analyses summarize which healthcare AI counts as high-risk under the EU AI Act and what already applies. For medical AI covered by the MDR/IVDR, the key date is 2 August 2028.
Who is affected and how
- medtech company
- Must align MDR/IVDR conformity assessment with the AI Act's August 2028 deadline.
- pharmaceuticals
- Should assess which of its internal AI tools fall into the high-risk category.
- hospital manager
- Should prepare for deployer obligations for triage AI and other systems under Annex III.
- health IT
- Should schedule documentation and compliance work around the deadlines.
Sources
- EU AI Act in Healthcare: What Applies and When | Lindsteadlindstead.com · Sep 29, 2026
- EU AI Act for Pharma: What Applies and When | Eunomiaeunomiapharmaservices.com · Sep 30, 2026
- EU AI Act for Medical Devices and Healthcare (MDR/IVDR)vdf.ai · Oct 2, 2026
- AI Act for medical devices delayed to August 2028: more time, same work – AI Compassing-engel.org · Oct 2, 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.