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Chapter I: General Provisions
Chapter II: Prohibited AI Practices
Chapter III: High-Risk AI Systems

Section 1: Classification of AI Systems as High-Risk

Section 2: Requirements for High-Risk AI Systems

Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties

Section 4: Notifying Authorities and Notified Bodies

Section 5: Standards, Conformity Assessment, Certificates, Registration

Chapter IV: Transparency Obligations for Providers and Deployers of Certain AI Systems
Chapter V: General-Purpose AI Models

Section 1: Classification Rules

Section 2: Obligations for Providers of General-Purpose AI Models

Section 3: Obligations of Providers of General-Purpose AI Models with Systemic Risk

Section 4: Codes of Practice

Chapter VI: Measures in Support of Innovation
Chapter VII: Governance

Section 1: Governance at Union Level

Section 2: National competent authorities

Chapter VIII: EU Database for High-Risk AI Systems
Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance

Section 1: Post-Market Monitoring

Section 2: Sharing of Information on Serious Incidents

Section 3: Enforcement

Section 4: Remedies

Section 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General-Purpose AI Models

Chapter X: Codes of Conduct and Guidelines
Chapter XI: Delegation of Power and Committee Procedure
Chapter XII: Penalties
Chapter XIII: Final Provisions
Annexes
Annex I
Annex II
Annex III
Annex IV
Annex V
Annex VI
Annex VII
Annex VIII
Annex IX
Annex X
Annex XI
Annex XII
Annex XIII
  • Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance
  • Section 2: Sharing of Information on Serious Incidents

Article 73: Reporting of serious incidents

Summary

This article details the reporting requirements for serious incidents involving high-risk AI systems. Providers must report incidents to market surveillance authorities within specific timeframes, depending on the severity. Reports must be made immediately for widespread infringements or deaths, and providers must conduct investigations and risk assessments. Authorities will take appropriate measures within seven days and notify the Commission of any serious incidents. The reporting obligations are adjusted for AI systems covered by other Union legislation.

The summaries are meant to provide helpful explanation but are not legal binding.

1.   Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred.

2.   The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident.

The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident.

3.   Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or a serious incident as defined in Article 3, point (49)(b), the report referred to in paragraph 1 of this Article shall be provided immediately, and not later than two days after the provider or, where applicable, the deployer becomes aware of that incident.

4.   Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the provider or the deployer has established, or as soon as it suspects, a causal relationship between the high-risk AI system and the serious incident, but not later than 10 days after the date on which the provider or, where applicable, the deployer becomes aware of the serious incident.

5.   Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial report that is incomplete, followed by a complete report.

6.   Following the reporting of a serious incident pursuant to paragraph 1, the provider shall, without delay, perform the necessary investigations in relation to the serious incident and the AI system concerned. This shall include a risk assessment of the incident, and corrective action.

The provider shall cooperate with the competent authorities, and where relevant with the notified body concerned, during the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the AI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.

7.   Upon receiving a notification related to a serious incident referred to in Article 3, point (49)(c), the relevant market surveillance authority shall inform the national public authorities or bodies referred to in Article 77(1). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1 of this Article. That guidance shall be issued by 2 August 2025 and shall be assessed regularly.

8.   The market surveillance authority shall take appropriate measures, as provided for in Article 19 of Regulation (EU) 2019/1020, within seven days from the date it received the notification referred to in paragraph 1 of this Article and shall follow the notification procedures as provided in that Regulation.

9.   For high-risk AI systems referred to in Annex III that are placed on the market or put into service by providers that are subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c).

10.   For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulations (EU) 2017/745 and (EU) 2017/746, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the Member States where the incident occurred.

11.   National competent authorities shall immediately notify the Commission of any serious incident, whether or not they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.

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