Article 3

(49)‘Significant incident’ means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: (a) the death of a person, or serious harm to a person’s health; (b) a serious and irreversible disruption of the management or operation of critical infrastructure; (c) the infringement of obligations under Union law intended to protect fundamental rights; (d) serious harm to property or the environment.

1.Providers of high-risk AI systems placed on the Union market shall report any significant incident via the single-entry point established pursuant to Article 23a of Directive (EU) 2022/2555, which it forwards to the market surveillance authorities of the Member States where that incident occurred without undue delay.

The Commission shall adopt delegated acts that lay down the specifications of a European template for reporting obligations under the single-entry point. Those delegated acts may harmonize reporting timelines, deadlines, thesholds and other data points in under this Act with those of other Union Acts. Those delegated acts shall be adopted in accordance with the examination procedure referred to in Article XX.