Article 11: Technical Documentation
Official Statutory Text
Article 11 Technical documentation 1. The technical documentation of a high-r isk AI system shall be drawn up before that system is placed on the marketor put into service and shall be kept up-to date. The technical documentation shall be drawn up in suchawayas to demonstrate that the high-r isk AI system complieswith the requirements setout in this Section and to provide national competent authorities and notified bodieswith 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 setout in Annex IV . SMEs, including star t-ups, may provide the elements of the technical documentation specified in Annex Ivin a simplified manner . To that end, the Commission shall establisha simplified technical documentation form targeted at the needs of small and microent er pr ises. Where an SME, including a star t-up, opts to provide the information required in Annex Ivin a simplified manner , it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformityassessment. 2. Where a high-r isk AI system related to a product covered by the Uni on harmonisation legislation listed in Section A of Annex I is placed on the marke tor put into service, a single setof technical documentation shall be drawn up containing all the information setout 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 lightof technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements setout in this Section.
European Parliament & Council (Regulation 2024/1689)
View Official EUR-Lex Publication- Providers of high-risk AI systems must draw up and keep up-to-date technical documentation before placing the system on the marketor putting it into service.
- The documentation must demonstrate compliance with requirements setout in Section 2 and provide national competent authorities and notified bodies with clear, comprehensive information to assess compliance, containing, at a minimum, the elements setout in Annex IV.
- SMEs, including start-ups, may provide Annex IV elements in a simplified manner using the form to be established by the Commission. Notified bodies must accept this simplified form for conformity assessment.
- Where a high-risk AI system is related to a product covered by Union harmonisation legislation listed in Annex I, Section A, a single setof technical documentation combining all required information shall be drawn up.
Applies directly across all 27 EU Member States with phased entry into force from 2025 to 2026.