The EU AI Regulation comes into force for high-risk systems

Since 2 August 2026, most of the requirements of the European AI Act have applied to high-risk AI systems, with specific provisions for medical devices incorporating AI.

2 August 2026 marks the date on which the majority of the obligations set out in the European AI Act for AI systems classified as high-risk will come into force, provided that the ‘Digital Omnibus’ agreement — which provides for the postponement of certain deadlines — has not been officially published in the Official Journal of the EU.

However, a specific regime applies to medical devices and in vitro diagnostic devices incorporating AI and subject to conformity assessment by a notified body: for these products, the deadline for compliance under the high-risk classification has been extended to August 2027, as opposed to August 2026, which was initially scheduled for other categories of high-risk systems.