Articles & guides
Next deadline
2 Dec 2026
Article 50(2) machine-readable marking for generative systems already on the market. Annex III high-risk applies from 2 December 2027, Annex I product AI from 2 August 2028.
Compliance by sector
Most medical AI is high-risk twice: once under the MDR or IVDR, once under Article 6(1). What doubles, what can share a notified body, and the 2028 date.