Article 73 Reporting of serious incidents

Providers means 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 charge; of high-risk AI systems means 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 environments; placed on the Union market shall report any serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment; to the market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; of the Member States where that incident occurred.

The report referred to in paragraph 1 shall be made immediately after the provider means 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 charge; has established a causal link between the AI system means 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 environments; and the serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment; or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the provider means 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 charge; or, where applicable, the deployer means 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 activity;, becomes aware of the serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment;.

The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment;.

Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement means any act or omission contrary to Union law protecting the interest of individuals, which: has harmed or is likely to harm the collective interests of individuals residing in at least two Member States other than the Member State in which: the act or omission originated or took place; the provider concerned, or, where applicable, its authorised representative is located or established; or the deployer is established, when the infringement is committed by the deployer; has caused, causes or is likely to cause harm to the collective interests of individuals and has common features, including the same unlawful practice or the same interest being infringed, and is occurring concurrently, committed by the same operator, in at least three Member States; or a serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment; 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 means 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 charge; or, where applicable, the deployer means 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 activity; becomes aware of that incident.

Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the provider means 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 charge; or the deployer means 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 activity; has established, or as soon as it suspects, a causal relationship between the high-risk AI system means 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 environments; and the serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment;, but not later than 10 days after the date on which the provider means 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 charge; or, where applicable, the deployer means 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 activity; becomes aware of the serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment;.

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

Following the reporting of a serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment; pursuant to paragraph 1, the provider means 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 charge; shall, without delay, perform the necessary investigations in relation to the serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment; and the AI system means 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 environments; concerned. This shall include a risk means the combination of the probability of an occurrence of harm and the severity of that harm; assessment of the incident, and corrective action.

The provider means 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 charge; shall cooperate with the competent authorities, and where relevant with the notified body means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; concerned, during the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the AI system means 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 environments; 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.

Upon receiving a notification related to a serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment; referred to in Article 3, point (49)(c), the relevant market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; 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.

The market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; 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.

For high-risk AI systems means 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 environments; referred to in Annex III that are placed on the market or put into service by providers means 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 charge; that are subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the notification of serious incidents means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment; shall be limited to those referred to in Article 3, point (49)(c).

For high-risk AI systems means 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 environments; which are safety components means a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property; of devices, or are themselves devices, covered by Regulations (EU) 2017/745 and (EU) 2017/746, the notification of serious incidents means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment; 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 means a notifying authority 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 Supervisor; chosen for that purpose by the Member States where the incident occurred.

National competent authorities means a notifying authority 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 Supervisor; shall immediately notify the Commission of any serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment;, whether or not they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.