Article 11: Technical Documentation
Article 11 requires providers to draw up technical documentation before a high-risk system is placed on the market, following the minimum content set out in Annex IV, and to keep it up to date. The documentation must demonstrate that the system meets the requirements of Articles 9 to 15 and give authorities enough information to assess conformity.
- 02 Dec 2027 Applies to Annex III high-risk systems
- 02 Aug 2028 Applies to Annex I embedded high-risk systems
- Draw up technical documentation before placing the system on the market or putting it into service.
- Follow the minimum content structure set out in Annex IV.
- Keep the documentation up to date to reflect changes to the system throughout its lifecycle.
- Make the documentation available to national authorities and the AI Office on request.
- Annex IV technical documentation package, version-controlled
Technical documentation is sometimes treated as a marketing-style spec sheet; Article 11 requires it to follow the specific Annex IV structure and to be kept current, not produced once and archived.
What regulators published on Art. 11
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- Regulation (EU) 2024/1689 on EUR-Lex
- Look for Article 11
- Deadline changes and the acts behind them
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Get free accessInformational content only. Not legal advice and not a substitute for qualified counsel. Dates reflect Regulation (EU) 2026/1744 as of 04 Aug 2026.