Chapter III · High-risk AI systems

Article 11 — Technical documentation

Provider

Official text

Each paragraph records where its wording comes from. Only text reproduced unchanged from the Official Journal is authentic; consolidated text is editorial and has no legal value. Paragraphs, subparagraphs and points each have their own link.

(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.

¶2

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.amended by Regulation (EU) 2026/1744

Consolidated text — no legal value · amended by Regulation (EU) 2026/1744

(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.

Authentic — as published in the Official Journal

(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.

Authentic — as published in the Official Journal

The formal analysis of Article 11

Article 6 is formalised first. The remaining articles follow.

Article 11 is formalised node by node: each rule as a deontic position with its operator, each exception with its rank, each predicate resolved against the definitions in Article 3.

What members get, per article

the rule logic: every norm as a formal position, with the defeater chain that decides which exception wins
the competency questions and their answers, every unanswered one marked as a gap and named
the ontology: predicates bound to AISV (AI Standardisation Vocabulary) and to the definitions they depend on, exportable as JSON-LD and OWL
the documentation: the Article 6(4) assessment record generated from a fact set, with its derivation and the version of the law it was decided against

Built for providers claiming the 6(3) derogation, for the counsel who has to defend that claim, and for the auditor who reads it afterwards.

Access is invite-only and opening in stages. Article 6 is formalised first; the remaining articles follow.

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What the article requiresUnder review

01Draw up the technical documentation before placing on the market or putting into service, and keep it up to date.
02Cover at least the Annex IV elements: general description, detailed description of the system and its development, monitoring, functioning and control, performance metrics, the risk management system under Article 9, lifecycle changes, standards applied, the EU declaration of conformity, and the post-market monitoring plan.
03Demonstrate compliance in a clear and comprehensive form for national competent authorities and notified bodies.
04Where the system relates to a product covered by the Union harmonisation legislation in Annex I, draw up a single set of documentation containing all required information.
05SME and start-up providers may supply the Annex IV elements in the simplified form provided by the Commission.

In practiceUnder review

Annex IV is a documentation graph, not a report: nearly every element is a pointer into another article's records. The cheapest way to keep it current is to generate it from the same structured model that holds the risk, data and logging records — which is exactly what the signed-in workspace does.

Standards addressing this articleUnder review

VocabularyUnder review

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