Article 11 requires providers to draw up comprehensive technical documentation before placing a high-risk AI system on the market. The content and structure of this documentation is specified in Annex IV and serves multiple purposes: it enables conformity assessment, supports market surveillance, and provides the information deployers need to use the system safely.
Annex IV Content Requirements
Annex IV specifies eight categories of information that technical documentation must contain: a general description of the AI system; a detailed description of the elements, development process, and training methodology; information on the monitoring, functioning, and control of the AI system; a description of the risk management system; a description of changes made throughout the lifecycle; a list of standards applied; a copy of the EU declaration of conformity; and post-market monitoring plan. This documentation must be kept up to date and be made available to national competent authorities upon request.
Regulation (EU) 2024/1689 — Article 11(1)
“Before a high-risk AI system is placed on the market or put into service, providers shall draw up technical documentation for that system. 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 shall provide national competent authorities and notified bodies with all the information necessary to assess the compliance of the AI system with those requirements.”
- Technical documentation must be prepared BEFORE market placement -- not retrospectively
- Annex IV, point 2(f) requires a detailed description of datasets used for training, validation, and testing
- Documentation must be updated whenever a substantial modification is made
- SMEs may use simplified formats but must provide the same substantive information
- Logs and audit trails required under Article 12 form part of the technical documentation record