When does Article 11 apply?

It applies from 2 Dec 2027 for high-risk systems listed in Annex III (Art. 113(c)(i), as amended), and from 2 Aug 2028 for high-risk systems covered by Annex I (Art. 113(c)(ii), as amended). Before Regulation (EU) 2026/1744, the dates were 2 Aug 2026 and 2 Aug 2027.

What is the maximum fine for breaching Article 11?

Up to €15 million or 3% of total worldwide annual turnover for the preceding financial year, whichever is higher (Art. 99(4), point (a), through the provider obligations in Art. 16). For SMEs, including start-ups, the fine is capped at whichever of the two is lower (Art. 99(6)). Since 27 Jul 2026, the same lower cap applies to small mid-cap enterprises (Art. 99(6a)).

Did the Digital Omnibus change Article 11?

Yes. Regulation (EU) 2026/1744, in force since 27 Jul 2026, makes these changes. Article 11(1): the simplified documentation form extends to SMCs. High-risk dates move to 2 Dec 2027 (Annex III) and 2 Aug 2028 (Annex I). The section "What changed" quotes the old and new text.

Is there an AiExponent tool for Article 11?

An alpha. Agentic Document Analyser is alpha software for Article 11. It writes a Technical file + logging extract.

Applies 2 Dec 2027

EU AI Act Article 11: Technical documentation

Article 11 of the EU AI Act requires that technical documentation for high-risk AI systems is drawn up before the system is placed on the market and kept up to date throughout its lifecycle. The documentation must cover the elements set out in Annex IV: system description, design specification, monitoring functioning, performance metrics, and any change-management.

Who: Providers of high-risk AI systems, before the system is placed on the market.
From when: 2 Dec 2027 (Annex III), 2 Aug 2028 (Annex I); Art. 113(c)(i), as amended
Maximum fine: €15M or 3%; Art. 99(4), point (a), through the provider obligations in Art. 16

Quoted from EUR-Lex

What Article 11 says

11(1), first subparagraph

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.

11(1), second subparagraph, as amended by Regulation (EU) 2026/1744

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.

Selected paragraphs, quoted exactly. Read the whole article in Regulation (EU) 2024/1689 on EUR-Lex. Checked 4 Oct 2026.

Regulation (EU) 2026/1744 · in force 27 Jul 2026

What changed

Change in lawArticle 11(1), second subparagraph

Removed: 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.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.

Removed and context lines quote Regulation (EU) 2024/1689 as adopted; added lines quote the amending Regulation.

Source: Regulation (EU) 2026/1744, Article 1, point (10), verified 4 Oct 2026

Change in lawArticle 113, third paragraph, point (c)

It shall apply from 2 August 2026.

~~Removed: (c) Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.~~(c) Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), shall apply from:(i) 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III; and(ii) 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I;

The context line is the second paragraph of Article 113, which set the date for Annex III systems before the change. Removed and context lines quote Regulation (EU) 2024/1689 as adopted; added lines quote the amending Regulation.

Source: Regulation (EU) 2026/1744, Article 1, point (40), verified 4 Oct 2026

In plain words

What you must produce

Technical documentation, drawn up before the system is placed on the market and kept up to date.

11(1)At a minimum, the elements set out in Annex IV
11(1), as amendedSMEs, start-ups and SMCs may use the simplified form the Commission establishes

A summary to help you plan. The quoted text above is the law.

Coverage: Alpha

Agentic Document Analyser

Agentic Document Analyser converts unstructured compliance documents (risk assessments, model cards, audit logs, contracts) into structured JSON for inclusion in an Annex IV technical documentation pack. The tool is alpha quality and Docker-only today; production hardening is on the post-launch roadmap. ADA is evidence-processing infrastructure, not a standalone Article 11 compliance product.

Run the alpha

bashdocker compose up

Writes: Technical file + logging extract

Open Agentic Document Analyser Docs and tool FAQ

From the fact register

Questions about Article 11

When does Article 11 apply?: It applies from 2 Dec 2027 for high-risk systems listed in Annex III (Art. 113(c)(i), as amended), and from 2 Aug 2028 for high-risk systems covered by Annex I (Art. 113(c)(ii), as amended). Before Regulation (EU) 2026/1744, the dates were 2 Aug 2026 and 2 Aug 2027.
What is the maximum fine for breaching Article 11?: Up to €15 million or 3% of total worldwide annual turnover for the preceding financial year, whichever is higher (Art. 99(4), point (a), through the provider obligations in Art. 16). For SMEs, including start-ups, the fine is capped at whichever of the two is lower (Art. 99(6)). Since 27 Jul 2026, the same lower cap applies to small mid-cap enterprises (Art. 99(6a)).
Did the Digital Omnibus change Article 11?: Yes. Regulation (EU) 2026/1744, in force since 27 Jul 2026, makes these changes. Article 11(1): the simplified documentation form extends to SMCs. High-risk dates move to 2 Dec 2027 (Annex III) and 2 Aug 2028 (Annex I). The section "What changed" quotes the old and new text.
Is there an AiExponent tool for Article 11?: An alpha. Agentic Document Analyser is alpha software for Article 11. It writes a Technical file + logging extract.

Content verified 4 Oct 2026 · Not legal advice.