Prepare and Maintain Technical Documentation for High-Risk AI Systems

1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date. That technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups, and SMCs, may provide the elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall establish a simplified technical documentation form targeted at the needs of SMEs, including start-ups, and SMCs. Where an SME, including a start-up, or an SMC, opts to provide the information required in Annex IV in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment. 2. Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section A of Annex I is placed on the market or put into service, a single set of technical documentation shall be drawn up containing all the information set out in paragraph 1, as well as the information required under those legal acts. 3. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this Section.

The technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to the relevant AI system: 1. A general description of the AI system including: (a) its intended purpose, the name of the provider and the version of the system reflecting its relation to previous versions; (b) how the AI system interacts with, or can be used to interact with, hardware or software, including with other AI systems, that are not part of the AI system itself, where applicable; (c) the versions of relevant software or firmware, and any requirements related to version updates; (d) the description of all the forms in which the AI system is placed on the market or put into service, such as software packages embedded into hardware, downloads, or APIs; (e) the description of the hardware on which the AI system is intended to run; (f) where the AI system is a component of products, photographs or illustrations showing external features, the marking and internal layout of those products; (g) a basic description of the user-interface provided to the deployer; (h) instructions for use for the deployer, and a basic description of the user-interface provided to the deployer, where applicable; 2. A detailed description of the elements of the AI system and of the process for its development, including: (a) the methods and steps performed for the development of the AI system, including, where relevant, recourse to pre-trained systems or tools provided by third parties and how those were used, integrated or modified by the provider; [Excerpt - see official source for complete provision]

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