European Union: Entry into force with grace period of AI Act including monitoring requirements for "high-risk AI systems"

On 1 August 2024, the regulation laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act) enters into force, 20 days following its publication in the Official Journal, with a grace period on its implementation. The Act includes post-deployment performance monitoring requirements for "high-risk" AI systems. The Act requires providers of high-risk AI systems to establish and document a post-marketing monitoring system, through which it actively collects data on the performance of high-risk AI systems in order to evaluate their compliance with the Regulation's requirements. Further, the Act would require providers of high-risk AI systems to report serious incidents to the market authorities of their respective member states. In general, providers are required to report a serious incident as soon as they establish a causal link between a high-risk system and a serious incident and, in any case, within 15 days of becoming aware of such an incident. The Act is generally implemented on 2 August 2026 after the lapse of the grace period, though some sections are subject to variable implementation periods. For high-risk AI systems as defined by Article 6(1), the Act only applies from 2 August 2027.