Source: OJ L, 2024/1689, 12.7.2024Current language: EN
- Artificial intelligence act
Basic legislative acts
- AI act regulation
Article 76 Supervision of testing in real world conditions by market surveillance authorities
Market surveillance authoritiesmeans the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; shall have competences and powers to ensure that testing in real world conditions is in accordance with this Regulation.
Where testing in real world conditions is conducted for AI systemsmeans 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; that are supervised within an AI regulatory sandboxmeans a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision; under Article 58, the market surveillance authoritiesmeans the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; shall verify the compliance with Article 60 as part of their supervisory role for the AI regulatory sandboxmeans a controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision;. Those authorities may, as appropriate, allow the testing in real world conditions to be conducted by the providermeans 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 prospective providermeans 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;, in derogation from the conditions set out in Article 60(4), points (f) and (g).
Where a market surveillance authoritymeans the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; has been informed by the prospective providermeans 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;, the providermeans 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 any third party of a serious incidentmeans 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 has other grounds for considering that the conditions set out in Articles 60 and 61 are not met, it may take either of the following decisions on its territory, as appropriate:
to suspend or terminate the testing in real world conditions;
to require the providermeans 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 prospective providermeans 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; and the deployermeans 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; or prospective deployermeans 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; to modify any aspect of the testing in real world conditions.
Where a market surveillance authoritymeans the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; has taken a decision referred to in paragraph 3 of this Article, or has issued an objection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor and how the providermeans 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 prospective providermeans 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; can challenge the decision or objection.
Where applicable, where a market surveillance authoritymeans the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; has taken a decision referred to in paragraph 3, it shall communicate the grounds therefor to the market surveillance authoritiesmeans the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; of other Member States in which the AI 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 environments; has been tested in accordance with the testing plan.
Relevant recitals
Recital 156 Powers of market surveillance authorities
In order to ensure an appropriate and effective enforcement of the requirements and obligations set out by this Regulation, which is Union harmonisation legislation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 should apply in its entirety. Market surveillance authoritiesmeans the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; designated pursuant to this Regulation should have all enforcement powers laid down in this Regulation and in Regulation (EU) 2019/1020 and should exercise their powers and carry out their duties independently, impartially and without bias. Although the majority of AI systemsmeans 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; are not subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to specific requirements and obligations under this Regulation, market surveillance authoritiesmeans the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; may take measures in relation to all AI systemsmeans 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; when they present a riskmeans the combination of the probability of an occurrence of harm and the severity of that harm; in accordance with this Regulation. Due to the specific nature of Union institutions, agencies and bodies falling within the scope of this Regulation, it is appropriate to designate the European Data Protection Supervisor as a competent market surveillance authoritymeans the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; for them. This should be without prejudice to the designation of national competent authoritiesmeans 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; by the Member States. Market surveillance activities should not affect the ability of the supervised entities to carry out their tasks independently, when such independence is required by Union law.
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