Source: OJ L, 2024/1689, 12.7.2024Current language: EN
- Artificial intelligence act
Basic legislative acts
- AI act regulation
Annex VI Conformity assessment procedure based on internal control
The conformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedure based on internal control is the conformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedure based on points 2, 3 and 4.
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; verifies that the established quality management system is in compliance with the requirements of Article 17.
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; examines the information contained in the technical documentation in order to assess the compliance of 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; with the relevant essential requirements set out in Chapter III, Section 2.
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; also verifies that the design and development process of 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; and its post-market monitoring as referred to in Article 72 is consistent with the technical documentation.
Relevant recitals
Recital 78 Conformity assessment procedures
The conformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedure provided by this Regulation should apply in relation to the essential cybersecurity requirements of a product with digital elements covered by a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements and classified as a high-risk 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; under this Regulation. However, this rule should not result in reducing the necessary level of assurance for critical products with digital elements covered by a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements. Therefore, by way of derogation from this rule, high-risk 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 fall within the scope of this Regulation and are also qualified as important and critical products with digital elements pursuant to a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements and to which the conformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedure based on internal control set out in an annex to this Regulation applies, are subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to the conformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; provisions of a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements insofar as the essential cybersecurity requirements of that regulation are concerned. In this case, for all the other aspects covered by this Regulation the respective provisions on conformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; based on internal control set out in an annex to this Regulation should apply. Building on the knowledge and expertise of ENISA on the cybersecurity policy and tasks assigned to ENISA under the Regulation (EU) 2019/881 of the European Parliament and of the Council(37)Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15)., the Commission should cooperate with ENISA on issues related to cybersecurity 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;.
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