Source: OJ L, 2024/1689, 12.7.2024
EN- Artificial intelligence act
Basic legislative acts
- AI act regulation
Article 74 Market surveillance and control of AI systems in the Union market
Regulation (EU) 2019/1020 shall apply to 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; covered by this Regulation. For the purposes of the effective enforcement of this Regulation:
any reference to an economic operator means a provider, product manufacturer, deployer, authorised representative, importer or distributor; under Regulation (EU) 2019/1020 shall be understood as including all operators means a provider, product manufacturer, deployer, authorised representative, importer or distributor; identified in Article 2(1) of this Regulation;
any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all 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; falling within the scope of this Regulation.
As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; shall report annually to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred during that year and about the measures taken.
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; related to products covered by the Union harmonisation legislation listed in Section A of Annex I, the market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; for the purposes of this Regulation shall be the authority responsible for market surveillance activities designated under those legal acts.
By derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another relevant authority to act as a market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020;, provided they ensure coordination with the relevant sectoral market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; responsible for the enforcement of the Union harmonisation legislation listed in Annex I.
The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to 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; related to products covered by the Union harmonisation legislation listed in section A of Annex I, where such legal acts already provide for procedures ensuring an equivalent level of protection and having the same objective. In such cases, the relevant sectoral procedures shall apply instead.
Without prejudice to the powers of market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; under Article 14 of Regulation (EU) 2019/1020, for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; may exercise the powers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.
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; placed on the market, put into service, or used by financial institutions regulated by Union financial services law, the market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; for the purposes of this Regulation shall be the relevant national authority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the market means the first making available of an AI system or a general-purpose AI model on the Union market;, putting into service means the supply of an AI system for first use directly to the deployer or for own use in the Union for its intended purpose;, or the use of 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; is in direct connection with the provision of those financial services.
By way of derogation from paragraph 6, in appropriate circumstances, and provided that coordination is ensured, another relevant authority may be identified by the Member State as market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; for the purposes of this Regulation.
National market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; supervising regulated credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism established by Regulation (EU) No 1024/2013, should report, without delay, to the European Central Bank any information identified in the course of their market surveillance activities that may be of potential interest for the prudential supervisory tasks of the European Central Bank specified 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; listed in point 1 of Annex III to this Regulation, in so far as the systems are used for law enforcement means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security; purposes, border management and justice and democracy, and 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; listed in points 6, 7 and 8 of Annex III to this Regulation, Member States shall designate as market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; for the purposes of this Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive (EU) 2016/680, or any other authority designated pursuant to the same conditions laid down in Articles 41 to 44 of Directive (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities, or otherwise interfere with their activities when acting in their judicial capacity.
Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as their market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020;, except in relation to the Court of Justice of the European Union acting in its judicial capacity.
Member States shall facilitate coordination between market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; designated under this Regulation and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed in Annex I, or in other Union law, that might be relevant for the 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.
Market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; and the Commission shall be able to propose joint activities, including joint investigations, to be conducted by either market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; or market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; jointly with the Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness or providing guidance in relation to this Regulation with respect to specific categories 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; that are found to present a serious risk means the combination of the probability of an occurrence of harm and the severity of that harm; across two or more Member States in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems and general-purpose AI models, and AI governance, provided for in Commission Decision of 24 January 2024; references in this Regulation to the AI Office shall be construed as references to the Commission; shall provide coordination support for joint investigations.
Without prejudice to the powers provided for under Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks, the market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; shall be granted full access 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; to the documentation as well as the training, validation and testing data means data used for providing an independent evaluation of the AI system in order to confirm the expected performance of that system before its placing on the market or putting into service; sets used for the development 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;, including, where appropriate and subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to security safeguards, through application programming interfaces (API) or other relevant technical means and tools enabling remote access.
Market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; shall be granted access to the source code of 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; upon a reasoned request and only when both of the following conditions are fulfilled:
access to source code is necessary to assess the conformity of a 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; with the requirements set out in Chapter III, Section 2; and
testing or auditing procedures and verifications based on the data and documentation provided by 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; have been exhausted or proved insufficient.
Any information or documentation obtained by market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; shall be treated in accordance with the confidentiality obligations set out in Article 78.
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