Article 11: Technical Documentation

Before first supply, providers must compile technical documentation that:

• Proves the high-risk system meets Section 2 requirements (Articles 8–15 and annexes)
• Is clear and comprehensive for national authorities and notified bodies
• Includes at least everything listed in Annex IV (general description, design, monitoring, human oversight, testing, cybersecurity, etc.)

Documentation must be kept up to date when the system or its claims change (substantial modifications trigger broader Chapter III work—see Article 12 and conformity routes).

SME carve-path: the Act contemplates a simplified documentation form for SMEs including start-ups; until the Commission form exists and you opt in, treat Annex IV as the baseline for everyone proportionate to risk.

Where a high-risk AI system relates to a product covered by Annex I Section A Union harmonisation legislation, Article 11(2) requires a single set of technical documentation containing both the AI Act information from paragraph 1 and the information required under the relevant sectoral legal acts—coordinate overlaps with your notified body early.

Article 11(3) empowers the Commission to adopt delegated acts under Article 97 to update Annex IV in light of technical progress, ensuring documentation requirements remain aligned with the state of the art.

• Article 8 — Technical documentation is core evidence for Section 2 compliance.
• Articles 9–10 — Risk and data artefacts feed Annex IV sections.
• Article 12 — Logging design and IFU must align with what Annex IV promises.
• Article 13 — Instructions for use must be consistent with Annex IV and runtime behaviour.
• Article 14 — Oversight measures are documented in Annex IV and explained to deployers.
• Article 49 — Registration entries should trace to documentation versions.
• Article 72 — Post-market data closes the loop on documentation claims.
• Article 97 — Delegated acts may update Annex IV (Article 11(3)).
• Article 113 — Application dates.

The following reproduces the complete text of Article 11 from the English consolidated text of Regulation (EU) 2024/1689 (OJ L 2024/1689).

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.

The recitals in the same consolidated AI Act on EUR-Lex contextualise technical documentation, conformity assessment, and SME proportionality. Use the official preamble on EUR-Lex—do not rely on unofficial recital lists without checking sequence and wording against the authentic text.