Article 11 requires the provider to draw up technical documentation BEFORE placing the system on the market and to keep it up to date thereafter. The contents are specified in Annex IV and cover everything from system description and design choices to training data, performance metrics, and risk management. Authorities can demand the documentation at any time under Art. 74. SMEs may use a simplified form maintained by the Commission. The documentation is the single most important artefact in any conformity assessment.
What you must do
- → Produce the Annex IV documentation set before market placement, not after.
- → Version-control it and update on every substantial modification.
- → Make it available to authorities in an EU language on request.
The authoritative text of Article 11 is published by the Publications Office of the European Union on EUR-Lex. We link directly to it rather than mirror it, so you always read the current consolidated version straight from the source.
Read Article 11 on EUR-LexSource: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act). The only authentic version is the one published in the Official Journal of the European Union.