Article 11 — Technical Documentation

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 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, 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. 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 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.

58/144 ELI: http://data.europa.eu/eli/reg/2024/1689/oj
OJ L, 12.7.2024 EN