Recital 173
(173)
In order to ensure that the regulatory framework can be adapted where necessary, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the conditions under which 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 not to be considered to be high-risk, the list of high-risk AI systems, the provisions regarding technical documentation, the content of the EU declaration of conformity the provisions regarding the 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) procedures, the provisions establishing the high-risk AI systems to which the 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) procedure based on assessment of the quality management system and assessment of the technical documentation should apply, the threshold, benchmarks and indicators, including by supplementing those benchmarks and indicators, in the rules for the classification of general-purpose AI models with systemic risksystemic riskmeans a risk that is specific to the high-impact capabilities of general-purpose AI models, having a significant impact on the Union market due to their reach, or due to actual or reasonably foreseeable negative effects on public health, safety, public security, fundamental rights, or the society as a whole, that can be propagated at scale across the value chainArticle 3(65), the criteria for the designation of general-purpose AI models with systemic risksystemic riskmeans a risk that is specific to the high-impact capabilities of general-purpose AI models, having a significant impact on the Union market due to their reach, or due to actual or reasonably foreseeable negative effects on public health, safety, public security, fundamental rights, or the society as a whole, that can be propagated at scale across the value chainArticle 3(65), the technical documentation for providers of general-purpose AI models and the transparency information for providers of general-purpose AI models. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making 55[OJ L 123, 12.5.2016, p. 1](https://eur-lex.europa.eu/legal-content/EN/AUTO/?uri=OJ:L:2016:123:TOC).. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
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