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Art.11High-Risk Classification and Requirements
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EU AI Act Art.11: Technical documentation

Article 11 of the EU AI Act binds the operator (see the article). It requires Technical documentation for a high-risk AI system shall be drawn up before the system is placed on the market or. This page states what it requires, who it binds and the evidence to keep. Browsing is free; the conformance kit is USD 499.

Specifics

InstrumentRegulation (EU) 2024/1689 (the EU AI Act), as amended by Regulation (EU) 2026/1744
ArticleArt.11
BindsOperator (see the article)
GroupHigh-Risk Classification and Requirements
Evidence items2
Linked NIST AI RMF controls4
Linked ISO/IEC 42001 controls5
Last updated

Who does Art.11 bind?

The article binds the operator (see the article). The Act places each duty on a named party in the value chain, so a system can carry a provider duty and a deployer duty at once. Confirm your own position against the text; this page names the party, it does not rule on your facts.

Applies with the high-risk regime: 2 December 2027 for stand-alone systems listed in Annex III, and 2 August 2028 for AI embedded in regulated products listed in Annex I (Article 113, as amended by Regulation (EU) 2026/1744). See the full timeline.

What does Art.11 require?

Technical documentation for a high-risk AI system shall be drawn up before the system is placed on the market or put into service and kept up to date. It shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the Section 2 requirements (incl Annex IV minimum content).

This is our plain-language statement of the article, not the text of the regulation. Read the article: Art.11 (Regulation (EU) 2024/1689 on EUR-Lex).

What evidence should we keep for Art.11?

CategoryEvidence to keep
Technical documentationAnnex IV-compliant technical documentation per high-risk system
Technical documentationDocument version control and update on material change

What does a linked control mean here?

A linked control is a NIST AI RMF or ISO/IEC 42001 control that the held rule set records as a topical match, with a confidence and a one-line reason. It does not establish that meeting one requirement satisfies the other, it is not legal advice, and it is not certification. Where no control is recorded, the page says so and does not guess. Sources: the NIST AI RMF and ISO/IEC 42001.

Which NIST AI RMF controls line up with Art.11?

4 controls in the held rule set is recorded as a topical match for this obligation, each with its confidence and reason.

ControlNIST AI RMFConfidence
AIRMF-GV-1.1Legal and regulatory requirements involving AI are understood, managed, and documented
The dossier demonstrates compliance but is not a register of applicable legal requirements.
medium
AIRMF-MN-4.1Post-deployment AI system monitoring plans are implemented, including mechanisms for capturing and evaluating input from users and other relevant AI actors, appeal and override, decommissioning, incident response, recovery, and change managementunstated
AIRMF-MP-2.1The specific task, and methods used to implement the task, that the AI system will support is defined
Annex IV documentation names the intended purpose, development methods and system architecture.
high
AIRMF-MS-2.1Test sets, metrics, and details about the tools used during test, evaluation, validation, and verification are documented
Annex IV requires the testing and validation procedures, test logs and test reports to be documented.
high

Which ISO/IEC 42001 controls line up with Art.11?

5 controls in the held rule set is recorded as a topical match for this obligation, each with its confidence and reason.

ControlISO/IEC 42001Confidence
A.4.2Resource documentation
Technical documentation records the development resources behind the system.
medium
A.4.4Tooling resources
Technical documentation covers development methods but tooling is not called out.
low
A.5.3Documentation of AI system impact assessments
Technical documentation retains the assessment evidence demonstrating compliance.
medium
A.6.2.3Documentation of AI system design and development
Technical documentation drawn up before market placement and kept up to date.
high
A.6.2.7AI system technical documentation
Technical documentation with Annex IV minimum content is drawn up and maintained.
high

What does the conformance kit add for Art.11?

The kit renders this obligation into your own role checklist with the evidence register, the linked controls and a CSV export, for USD 499 one off. See what is in the kit or open it.