Which events must be reported, and by whom?
The provider normally reports to the market surveillance authorities where the occurred. If amended Article 75(1a) places the system under the AI Office's exclusive competence, report there instead. Article 3(49) covers incidents or malfunctions that directly or indirectly cause death or serious health harm; serious and irreversible disruption of critical infrastructure; infringement of EU-law duties protecting fundamental rights; or serious property or environmental harm.
Report immediately after establishing a causal link or a reasonable likelihood of one, subject to the outer deadline measured from awareness. Do not wait for a complete root-cause investigation. A malfunction without a listed serious outcome may still require monitoring, risk review or corrective action.
Article 73 has sector-specific reporting limits. For Annex III systems whose providers are already subject to equivalent Union reporting duties, the AI Act notification is limited to incidents involving infringement of Union-law obligations protecting fundamental rights. The same limit applies to high-risk AI that is, or is a safety component of, a medical device or in vitro diagnostic device under Regulations (EU) 2017/745 or 2017/746; that report goes to the national competent authority selected by the Member State where the incident occurred.
- Confirm that the system is a high-risk AI system and that the event fits one of the Article 3 serious-incident outcomes.
- Identify the Member State or Member States where the incident occurred because Article 73 points the report to those market surveillance authorities.
- Record when the provider, or where applicable the deployer, became aware of the .
- Record when the causal link or reasonable likelihood of a causal link was established, because that determines when the report must be made immediately.
Who reports a high-risk system incident?
The provider of the high-risk AI system owns the report. It normally reports to the market surveillance authorities of the Member States where the incident occurred. From 27 July 2026, amended Article 75(1a) requires a provider whose system falls under the AI Office's exclusive competence to report to the AI Office instead. A deployer that identifies a must immediately inform the provider first, then the importer or distributor and the relevant authority; if the provider cannot be reached, the deployer follows Article 73 with the necessary adjustments to its role, rather than waiting for contact to be restored.
Must causation be proven before reporting?
No. Article 73 triggers reporting immediately after the provider has established either a causal link between the AI system and the or the reasonable likelihood of such a link. For a death-related incident, the report is due immediately after the provider or deployer establishes, or as soon as it suspects, a causal relationship, subject to the Article 73 outer deadline.
Do equivalent sector rules remove all AI Act reports?
No. Article 73(9) limits AI Act reports for Annex III systems covered by equivalent Union reporting duties to incidents involving infringement of Union-law obligations protecting fundamental rights. Article 73(10) applies the same limited category to high-risk AI that is, or is a safety component of, a medical device or in vitro diagnostic device, with reporting to the Member State's selected national competent authority. The provider should document the equivalent regime and the specific Article 3(49)(c) screening result.
Citations (1)
- Regulation (EU) 2024/1689 (Artificial Intelligence Act)
Supports the Article 3 serious-incident definition, Article 26 deployer escalation, and Article 73 reporting duty for high-risk AI systems.
Providers of high-risk AI systems placed on the Union market shall report any serious incident