Article 73 — Reporting of Serious Incidents

Article 73

Reporting of serious incidents

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.

ELI: http://data.europa.eu/eli/reg/2024/1689/oj 101/144
EN OJ L, 12.7.2024

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.

SECTION 3

Enforcement