Article 11 — Technical documentation
AI Act, Regulation (EU) 2024/1689
What does AI Act Article 11 say?
Short answer, straight from the official text
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 …
Source: AI Act, Regulation (EU) 2024/1689, read 2026-08-14.
| In the act | EU 2024/1689 |
| Chapter | III · High-risk AI systems |
| CELEX | 32024R1689 |
| Read on | 2026-08-14 |
Official text
Read from the EU Publications Office for this CELEX number. The wording stands as published; nothing here is rewritten or summarised.
Jump to a point: Point 1 · Point 2 · Point 3
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 to provide national competent authorities and notified bodies with 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. SMEs, including start-ups, may provide the elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall establish a simplified technical documentation form targeted at the needs of small and microenterprises. Where an SME, including a start-up, opts to provide the information required in Annex IV in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.
2. Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section A of 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 paragraph 1, as well as the information required under those legal acts.
The article continues in the official text.
Other articles in this chapter
- Article 6
- Article 7
- Article 8
- Article 9
- Article 10
- Article 12
- Article 13
- Article 14
- Article 15
- Article 16
- Article 17
- Article 18
Decision guide
Who is affected?
- Providers of high-risk AI systems. (Art. 11(1))
- SMEs, including start-ups, and small mid-cap enterprises (SMCs) may provide it in a simplified manner, using the Commission's form. (Art. 11(1))
Questions and answers
When must the technical documentation exist? Before the high-risk system is placed on the market or put into service, and it must be kept up to date. (Art. 11(1))
What must it contain? At least the elements set out in Annex IV, so that authorities can assess compliance with the requirements for high-risk systems. (Art. 11(1))
What if the AI relates to a product under the legislation in Section A of Annex I? A single set of technical documentation is drawn up, containing the Annex IV information as well as that required by the product legislation. (Art. 11(2))
Duties
| Who | What | From |
|---|---|---|
| Provider | Draw up technical documentation per Annex IV before launch and keep it current. (Art. 11(1)) | 2 December 2027 (Annex III systems); 2 August 2028 (Annex I systems) |
Risk
Breach of provider obligations under Article 16, which include Article 11: fine up to EUR 15 million or 3 % of worldwide annual turnover. (Art. 99(4)(a))
Most common mistake
Writing the documentation after launch. The text requires it before placing on the market. (Art. 11(1))
Most common sanction
No published supervisory decision under this article yet. Fines under the AI Act can be imposed from 2 August 2025 (Art. 113).
Actions
- Does this apply to us: check whether the system is high-risk under Article 6.
- What must we do: fill in each Annex IV heading before launch and set an update routine.
- What does a mistake cost: up to EUR 15 million or 3 % of turnover.
Checked against the official text: 2026-10-12
The text is quoted from the official source and is not legal advice. A national court reads the language version that binds in its jurisdiction.
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