--- authoritative: false representation: annotated-page publisher: AstroKube methodology: https://ai-act.astrokube.com/about/ source_verified_on: '2026-09-15' site_content_updated_on: '2026-09-15' title: 'Article 11: Technical documentation | EU AI Act | AstroKube' description: 'Article 11, EU AI Act: 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…' language: en source: https://ai-act.astrokube.com/law/art-11/ --- 1. [Start](https://ai-act.astrokube.com/) 2. [The law](https://ai-act.astrokube.com/law/) 3. Article 11 Chapter III · Section 2 · Requirements for high-risk AI systems # Article 11 — Technical documentation ⟲ Amended · Regulation (EU) 2026/1744 ▼ Primary text, verbatim. Our annotations appear below, visibly separated. [1\.](https://ai-act.astrokube.com/law/art-11/#p-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. That 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, and SMCs, 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 SMEs, including start-ups, and SMCs. Where an SME, including a start-up, or an SMC, 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\.](https://ai-act.astrokube.com/law/art-11/#p-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. [3\.](https://ai-act.astrokube.com/law/art-11/#p-3) The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this Section. This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. **Amended** — Regulation (EU) 2026/1744 Passages marked with the accent edge in the primary text were inserted or replaced by the amendment. Show the text as adopted, before the amendment The authentic 2024 text of this provision, shown for comparison. It no longer states the law. 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. 3\. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this Section. [ Recital 66 — interpretive context Requirements should apply to high-risk AI systems as regards risk management, the quality and relevance of data sets used, technical documentation and record-keeping, transparency and the provision of information to deployers, human oversight, and robustness, accuracy and cybersecurity. Those requirements are necessary to effectively mitigate the risks for health, safety and fundamental rights. As no other less… ](https://ai-act.astrokube.com/law/recital-66/)[ Recital 71 — interpretive context Having comprehensible information on how high-risk AI systems have been developed and how they perform throughout their lifetime is essential to enable traceability of those systems, verify compliance with the requirements under this Regulation, as well as monitoring of their operations and post market monitoring. This requires keeping records and the availability of technical documentation, containing information… ](https://ai-act.astrokube.com/law/recital-71/) ## What this means for you In your terms · Technical documentation The Annex IV file describes your system, and drift makes it wrong. Generate what can be generated from the source of truth instead of hand-maintaining prose. - Annex IV technical file - Doc generation wired into CI Failure smells likeThe documentation describes the system as it was designed two releases ago, and nothing in the pipeline forces it to move with the code. ## Obligations derived from this article [Technical documentationArt. 11](https://ai-act.astrokube.com/explorer/?art=art-11) ## If you would rather not read the law The basics page explains the Regulation's own categories in order: scope, role, tier, date. The engineering view groups the obligations by the platform capability they demand. [Start with the basics →](https://ai-act.astrokube.com/basics/) [Open the engineering view →](https://ai-act.astrokube.com/engineering/) ## About this provision ### Status Upcoming 2 Dec 2027 Moved from ~2 Aug 2026~ ### Regime High-risk ### Binds Provider ### Type Article · Chapter III · Section 2 ### Amended by [Regulation (EU) 2026/1744](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02024R1689-20260727) ### Recitals [66](https://ai-act.astrokube.com/law/recital-66/) [71](https://ai-act.astrokube.com/law/recital-71/) ### Related [Article 12](https://ai-act.astrokube.com/law/art-12/) [Article 18](https://ai-act.astrokube.com/law/art-18/) [Annex IV](https://ai-act.astrokube.com/law/annex-iv/) ### Cited capture regulation-2024-1689/en-2026-08-18.html sha256 8f0b656302f9864c… [Authentic text (EUR-Lex) →](http://data.europa.eu/eli/reg/2024/1689/oj) [This version (EUR-Lex) →](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02024R1689-20260727) ### Machine readable [/law/art-11.md](https://ai-act.astrokube.com/law/art-11.md) [/api/law.json](https://ai-act.astrokube.com/api/law.json) ### Found an error? 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