On 2 August 2027, the regulation laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act) comes into effect for "high-risk AI systems" referred to in Article 6(1) of the Act. 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.
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