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 to demonstrate that the high-risk AI system complies with the requirements set out in this Chapter and provide national competent authorities and notified bodies with all 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 or, in the case of SMEs, including start-ups, any equivalent documentation meeting the same objectives, unless deemed inappropriate by the competent authority.

2. Where a high-risk AI system related to a product, to which the legal acts listed in Annex II, section A apply, is placed on the market or put into service one single technical documentation shall be drawn up containing all the information set out in Annex IV as well as the information required under those legal acts.

3. The Commission is empowered to adopt delegated acts in accordance with Article 73 to amend Annex IV where necessary to ensure that, in the light of technical progress, the technical documentation provides all the necessary information to assess the compliance of the system with the requirements set out in this Chapter.