Regulation
EU AI Act
EU regulation classifying AI by risk; high-risk AI in regulated products faces extra obligations.
The EU AI Act classifies AI systems by risk. AI used in regulated products like medical devices is treated as high-risk under Article 6(1), with obligations layered onto the existing MDR conformity assessment. Compliance deadlines have shifted through 2026 — the relevant dates for healthcare AI are now expected in 2027–2028 for most embedded-AI obligations.
The AI Act was cited by OpenEvidence as the reason it voluntarily withdrew from the EU and UK in spring 2026.
See also
- EU MDR (Regulation 2017/745) — EU Medical Device Regulation — governs healthcare software that has a medical purpose.
- Annex VIII, Rule 11 (EU MDR) — The MDR rule that classifies decision-informing healthcare software as a regulated device.