---
title: "Art. 11 AI Act: Technical documentation"
canonical: "https://dposchool.com/ai-act/article/11"
source: "https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02024R1689-20260727#art_11"
source_note: "Source: Regulation (EU) 2024/1689, OJ L, 2024/1689, 12.7.2024; articles and annexes from the consolidated text 02024R1689-20260727. Only the text published in the Official Journal is authentic. © European Union, https://eur-lex.europa.eu"
text_as_of: "2026-07-27"
language: "en"
publisher: "DPO School"
---

Art. 11 AI Act · Chapter III: HIGH-RISK AI SYSTEMS · Section 2: Requirements for high-risk AI systems

# Article 11 AI Act: Technical documentation

Consolidated text of 27 July 2026. Retrieved 30 October 2026.

## Official text

### Article 11(1)

**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.

### Article 11(2)

**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.

### Article 11(3)

**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.

## Source

Source: Regulation (EU) 2024/1689, OJ L, 2024/1689, 12.7.2024; articles and annexes from the consolidated text 02024R1689-20260727. Only the text published in the Official Journal is authentic. © European Union, https://eur-lex.europa.eu

[Article 11 on EUR-Lex](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02024R1689-20260727#art_11)

Consolidated text of 27 July 2026. Retrieved 30 October 2026.

This is reference material, not legal advice.

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