Article 75: Market surveillance and control of AI systems and mutual assistance
1.
The AI OfficeAI Officemeans 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 CommissionArticle 3(47) shall be exclusively competent for the supervision and enforcement of the obligations under this Regulation in relation to the following AI systems:Where 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) is based on a general-purpose AI modelgeneral-purpose AI modelmeans an AI model, including where such an AI model is trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable of competently performing a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into a variety of downstream systems or applications, except AI models that are used for research, development or prototyping activities before they are placed on the marketArticle 3(63), and the model and the system are developed by the same 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), the AI OfficeAI Officemeans 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 CommissionArticle 3(47) shall have powers to monitor and supervise compliance of that 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) with obligations under this Regulation. To carry out its monitoring and supervision tasks, the AI OfficeAI Officemeans 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 CommissionArticle 3(47) shall have all the powers of a 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) provided for in this Section and Regulation (EU) 2019/1020.
(a)
AI systems based on general-purpose AI models where the model and the system are developed by the same 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 by providers forming part of the same undertaking as that 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), with the exception of:Not present before the amendment.
(i)
AI systems related to products covered by the Union harmonisation legislation listed in Annex I;Not present before the amendment.
(iii)
AI systems provided by law enforcementlaw enforcementmeans 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 securityArticle 3(46) authorities, border management authorities and financial institutions, insofar as those AI systems fall under Article 74(6); andNot present before the amendment.
(iv)
AI systems referred to in point 8 of Annex III as regards the administration of justice;Not present before the amendment.
(b)
AI systems that constitute or that are integrated into a very large online platform or very large online search engine designated in accordance with Regulation (EU) 2022/2065.Not present before the amendment.
The exclusive competence referred to in the first subparagraph shall apply to the providers of those systems. It shall apply to the deployers of those systems only when they are also 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 form part of the same undertaking as 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).Not present before the amendment.
1a.
By way of derogation from Article 73, providers of high-risk AI systems subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58) to the competence of the AI OfficeAI Officemeans 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 CommissionArticle 3(47) pursuant to paragraph 1 of this Article shall report any serious incidents to the AI OfficeAI Officemeans 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 CommissionArticle 3(47). Article 73 (2) to (9), shall apply mutatis mutandis. The AI OfficeAI Officemeans 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 CommissionArticle 3(47) shall promptly transmit the relevant information to 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) of the Member State in the territory of 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 its legal representative is situated.Not present before the amendment.
1b.
The authorities involved in the application of this Regulation shall cooperate actively with the AI OfficeAI Officemeans 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 CommissionArticle 3(47) and provide the AI OfficeAI Officemeans 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 CommissionArticle 3(47) the necessary assistance for the exercise of its powers, including, where necessary, in connection with inspections or other enforcement measures carried out in the territory of a Member State. To that end, those authorities shall enjoy the powers provided for pursuant to this Regulation and Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks under this paragraph, in accordance with the applicable national procedures.Not present before the amendment.
1c.
When taking investigatory or enforcement action in the territory of a Member State that involves access to a public authority’s data or 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), the AI OfficeAI Officemeans 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 CommissionArticle 3(47) shall be assisted by 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).Not present before the amendment.
1d.
Before taking a decision that would have the effect of prohibiting or restricting 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) being made available or put into service on a national market, or a decision to withdraw or recall 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) from such market, the AI OfficeAI Officemeans 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 CommissionArticle 3(47) shall, without undue delay, notify 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) competent for that market of its intention to take such a decision. The AI OfficeAI Officemeans 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 CommissionArticle 3(47) shall consult the authorities involved in the application of this Regulation, where appropriate, on any matter relating to the application and enforcement of this Regulation.Not present before the amendment.
1e.
The AI OfficeAI Officemeans 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 CommissionArticle 3(47) shall be responsible for conformity assessments and tests of AI systems referred to in paragraph 1 of this Article that are classified as high-risk and subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58) to a third-party conformity assessmentconformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a 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) have been fulfilledArticle 3(20) pursuant to Article 43 before such AI systems are placed on the market or put into service. Those tests and assessments shall verify that the systems comply with the relevant requirements of this Regulation and may be placed on the market or put into service in the Union in accordance with this Regulation. The Commission shall entrust the performance of those tests or assessments to notified bodies designated in accordance with this Regulation, in which case the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) shall act on behalf of the Commission. If a notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) to which the Commission has delegated tasks under this paragraph does not perform those tasks adequately, the Commission may withdraw the delegation with immediate effect.Not present before the amendment.
The fees for testing and assessment activities shall be levied on 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) of a 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) who has applied for a third-party conformity assessmentconformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a 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) have been fulfilledArticle 3(20) to the Commission. 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 pay the costs related to the services entrusted by the Commission to the notified bodies in accordance with this Article directly to the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22).Not present before the amendment.
2.
Where the relevant market surveillance authorities have sufficient reason to consider general-purpose AI systems that can be used directly by deployers for at least one purpose that is classified as high-risk pursuant to this Regulation to be non-compliant with the requirements laid down in this Regulation, they shall cooperate with the AI OfficeAI Officemeans 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 CommissionArticle 3(47) to carry out compliance evaluations, and shall inform the Board and other market surveillance authorities accordingly.
2a.
Where a 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) has well-founded and sufficient reasons to suspect that a 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 a 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) 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) referred to in paragraph 1 of this Article has infringed this Regulation, it may request, through the relevant single point of contact designated in accordance with Article 70(2), the AI OfficeAI Officemeans 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 CommissionArticle 3(47) to assess the matter in order to take the necessary supervisory and enforcement measures to ensure prompt compliance with this Regulation. Such a request shall be duly reasoned and shall include at least:Not present before the amendment.
(a)
the name of 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) concerned;Not present before the amendment.
(b)
a description of the relevant facts, the provisions of this Regulation that have allegedly been infringed, and any well-founded and sufficient reasons for suspecting an infringement, including, where applicable, the description of the negative effects of the alleged infringement;Not present before the amendment.
(c)
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) making the request.Not present before the amendment.
The AI OfficeAI Officemeans 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 CommissionArticle 3(47) shall take utmost account of the request and 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 cooperate actively and provide the AI OfficeAI Officemeans 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 CommissionArticle 3(47) the necessary assistance for the exercise of its powers in accordance with paragraph 1a.Not present before the amendment.
The AI OfficeAI Officemeans 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 CommissionArticle 3(47) shall, without undue delay and in any event no later than four months following receipt of the request, inform the single point of contact of its intention to exercise its powers in accordance with Article 75a or of its reasons for not exercising its powers. If the AI OfficeAI Officemeans 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 CommissionArticle 3(47) decides to exercise its powers in accordance with Article 75a, it shall periodically inform that single point of contact about major developments in the proceedings and the outcome of such proceedings, without disclosing any confidential information.Not present before the amendment.
3.
Where a 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) is unable to conclude its investigation of 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) because of its inability to access certain information related to the general-purpose AI modelgeneral-purpose AI modelmeans an AI model, including where such an AI model is trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable of competently performing a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into a variety of downstream systems or applications, except AI models that are used for research, development or prototyping activities before they are placed on the marketArticle 3(63) despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the AI OfficeAI Officemeans 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 CommissionArticle 3(47), by which access to that information shall be enforced. In that case, the AI OfficeAI Officemeans 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 CommissionArticle 3(47) shall supply to the applicant authority without delay, and in any event within 30 days, any information that the AI OfficeAI Officemeans 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 CommissionArticle 3(47) considers to be relevant in order to establish whether a 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) is non-compliant. Market surveillance authorities shall safeguard the confidentiality of the information that they obtain in accordance with Article 78 of this Regulation. The procedure provided for in Chapter VI of Regulation (EU) 2019/1020 shall apply mutatis mutandis.