Article 11

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 provide national competent authorities and notified bodies with all the necessary information to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV.

2. Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in 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 Annex IV as well as the information required under those legal acts.

3. The Commission is empowered to adopt delegated acts to amend Annex IV where necessary to ensure that, in 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 Section.