Section 2
Sharing of information on serious incidents
Article 73: Reporting of Serious Incidents
1.
Providers of high-risk AI systems placed on the Union market shall report any serious incidentserious incidentmeans an incident or malfunctioning of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) that directly or indirectly leads to any of the following:Article 3(49) 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 providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3) has established a causal link between the AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) and the serious incidentserious incidentmeans an incident or malfunctioning of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) that directly or indirectly leads to any of the following:Article 3(49) or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3) or, where applicable, the deployerdeployermeans a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activityArticle 3(4), becomes aware of the serious incidentserious incidentmeans an incident or malfunctioning of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) that directly or indirectly leads to any of the following:Article 3(49).
The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incidentserious incidentmeans an incident or malfunctioning of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) that directly or indirectly leads to any of the following:Article 3(49).
3.
Notwithstanding paragraph 2 of this Article, in the event of a widespread infringementwidespread infringementmeans any act or omission contrary to Union law protecting the interest of individuals, which:Article 3(61) or a serious incidentserious incidentmeans an incident or malfunctioning of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) that directly or indirectly leads to any of the following:Article 3(49) 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 providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3) or, where applicable, the deployerdeployermeans a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activityArticle 3(4) 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 providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3) or the deployerdeployermeans a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activityArticle 3(4) has established, or as soon as it suspects, a causal relationship between the high-risk AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) and the serious incidentserious incidentmeans an incident or malfunctioning of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) that directly or indirectly leads to any of the following:Article 3(49), but not later than 10 days after the date on which the providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3) or, where applicable, the deployerdeployermeans a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activityArticle 3(4) becomes aware of the serious incidentserious incidentmeans an incident or malfunctioning of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) that directly or indirectly leads to any of the following:Article 3(49).
5.
Where necessary to ensure timely reporting, the providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3) or, where applicable, the deployerdeployermeans a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activityArticle 3(4), may submit an initial report that is incomplete, followed by a complete report.
6.
Following the reporting of a serious incidentserious incidentmeans an incident or malfunctioning of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) that directly or indirectly leads to any of the following:Article 3(49) pursuant to paragraph 1, the providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3) shall, without delay, perform the necessary investigations in relation to the serious incidentserious incidentmeans an incident or malfunctioning of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) that directly or indirectly leads to any of the following:Article 3(49) and the AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) concerned. This shall include a risk assessment of the incident, and corrective action.
The providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3) shall cooperate with the competent authorities, and where relevant with the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) concerned, during the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) 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 incidentserious incidentmeans an incident or malfunctioning of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) that directly or indirectly leads to any of the following:Article 3(49) referred to in Article 3, point (49)(c), the relevant market surveillance authoritymarket surveillance authorityAny national authority responsible for carrying out market surveillance on the territory of the Member State concernedRegulation (EU) 2019/1020 Art. 3(4) 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 authoritymarket surveillance authorityAny national authority responsible for carrying out market surveillance on the territory of the Member State concernedRegulation (EU) 2019/1020 Art. 3(4) 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 subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58) 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 authoritynational competent authoritymeans a notifying authoritynotifying authoritymeans the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoringArticle 3(19) or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection SupervisorArticle 3(48) chosen for that purpose by the Member States where the incident occurred.
11.
National competent authorities shall immediately notify the Commission of any serious incidentserious incidentmeans an incident or malfunctioning of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) that directly or indirectly leads to any of the following:Article 3(49), whether or not they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.