Article 11 Technical documentation

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.

The 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 authoritiesas defined in Article 46 and notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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, 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 small and microenterprises, ‘small enterprises’ and ‘medium-sized enterprises’ mean, respectively, microenterprises, small enterprises and medium-sized enterprises as defined in the Annex to Recommendation 2003/361/EC;. Where an SME, including a start-up, 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 means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall accept the form for the purposes of the conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled;.

Where a high-risk AI system related to a product covered by the Union harmonisation legislation means Union legislation listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for the marketing of products to which that Regulation applies; 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.

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.