in force 2026-07-27 MODIFIED+54 −25§
Amended by Digital Omnibus on AI 32026R1744
applies from: unchanged
The provision now extends the option to submit simplified technical documentation, and the corresponding simplified form, to SMCs alongside SMEs and start-ups, whereas previously it referred only to SMEs and start-ups.
The opening reference in paragraph 1 was also changed from 'The technical documentation' to 'That technical documentation'.
Cited: Art. 11, v1 · Art. 11, v2
text before / after
32024R1689 → 02024R1689-20260727
Article 11
Technical documentation
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.
The 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 small SMEs, including start-ups, and microenterprises. 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.