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Art. 11 and Annex IV: Technical documentation under the EU AI Act

Art. 11(1) requires the provider to draw up the technical documentation of a high-risk AI system before placing on the market or putting into service, and to keep it up to date. The documentation contains at least the elements in Annex IV sections 1 to 9. In this mapping, 12 elements are testable as consistency checks between declared values and evidence, 19 are documentation, and 4 are process. Regulation (EU) 2026/1744 moved the application date for Annex III systems (Deferred) and left the content of the obligation unchanged.

Where this applies

What the text requires

Annex IV is the content list; Art. 11 sets when the documentation exists and what it demonstrates. A documentation element becomes testable where the text names a value or a fact that another artefact also records, such as a declared accuracy level in Annex IV section 3 and the test report in section 2(g).

What the text requires and how each element is verified
RequiresTestableDocumentationProcess
  1. Art. 11(1) first subparagraphThe provider draws up the technical documentation of a high-risk AI system before the system is placed on the market or put into service. The provider keeps the documentation up to date.
  2. Art. 11(1) second subparagraphThe technical documentation demonstrates that the high-risk AI system meets the requirements set out in Chapter III Section 2. It gives national competent authorities and notified bodies the necessary information in a clear and comprehensive form to assess the system against those requirements. It contains, at a minimum, the elements set out in Annex IV.
  3. Art. 11(1) third subparagraphSMEs, including start-ups, and SMCs (small mid-cap enterprises) may provide the elements of the technical documentation specified in Annex IV in a simplified manner. The Commission establishes a simplified technical documentation form targeted at the needs of SMEs, including start-ups, and SMCs. An SME, including a start-up, or an SMC that opts to provide the Annex IV information in a simplified manner uses that form. Notified bodies accept the form for the purposes of the conformity assessment.
  4. Art. 11(2)Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Annex I Section A is placed on the market or put into service, the provider draws up a single set of technical documentation. That set contains all the information set out in Art. 11(1) and the information required under those legal acts.
  5. Art. 11(3)The Commission is empowered to adopt delegated acts in accordance with Art. 97 to amend Annex IV where necessary. The purpose is that, in light of technical progress, the technical documentation provides all the information necessary to assess the system against the requirements of Chapter III Section 2.
  6. Annex IV introductionThe technical documentation referred to in Art. 11(1) contains at least the information listed in Annex IV sections 1 to 9, as applicable to the relevant AI system.
  7. Annex IV section 1(a)The general description of the AI system states its intended purpose. It includes the specific context and conditions of use as specified in the instructions for use, in promotional or sales materials and statements, and in the technical documentation. It states the name of the provider. It states the version of the system and the relation of that version to previous versions.
  8. Annex IV section 1(b)The general description states how the AI system interacts with, or can be used to interact with, hardware or software that is not part of the AI system itself, including other AI systems, where applicable.
  9. Annex IV section 1(c)The general description states the versions of relevant software or firmware and any requirements related to version updates.
  10. Annex IV section 1(d)The general description describes all the forms in which the AI system is placed on the market or put into service, such as software packages embedded into hardware, downloads or APIs.
  11. Annex IV section 1(e)The general description describes the hardware on which the AI system is intended to run.
  12. Annex IV section 1(f)Where the AI system is a component of products, the general description includes photographs or illustrations that show the external features, the marking and the internal layout of those products.
  13. Annex IV section 1(g)The general description includes a basic description of the user interface provided to the deployer.
  14. Annex IV section 1(h)The general description includes the instructions for use for the deployer. It includes a basic description of the user interface provided to the deployer, where applicable.
  15. Annex IV section 2(a)The detailed description states the methods and steps performed for the development of the AI system. Where relevant, it states the recourse to pre-trained systems or tools provided by third parties and how the provider used, integrated or modified them.
  16. Annex IV section 2(b)The detailed description states the design specifications of the system. These are the general logic of the AI system and of the algorithms; the key design choices with the rationale and the assumptions made, including with regard to the persons or groups of persons on whom the system is intended to be used; the main classification choices; what the system is designed to optimise for and the relevance of the different parameters; the expected output and output quality of the system; and the decisions about any trade-off made in the technical solutions adopted to comply with the requirements of Chapter III Section 2.
  17. Annex IV section 2(c)The detailed description describes the system architecture. It explains how software components build on or feed into each other and integrate into the overall processing. It states the computational resources used to develop, train, test and validate the AI system.
  18. Annex IV section 2(d)Where relevant, the detailed description states the data requirements in the form of datasheets. The datasheets describe the training methodologies and techniques and the training data sets used. They give a general description of the data sets, information about their provenance, scope and main characteristics, how the data was obtained and selected, the labelling procedures and the data cleaning methodologies.
  19. Annex IV section 2(e)The detailed description includes an assessment of the human oversight measures needed in accordance with Art. 14. It includes an assessment of the technical measures needed to facilitate the interpretation of the outputs of the AI system by the deployers, in accordance with Art. 13(3)(d).
  20. Annex IV section 2(f)Where applicable, the detailed description gives a detailed account of pre-determined changes to the AI system and its performance. It gives all the relevant information on the technical solutions adopted so that the AI system continues to meet the requirements of Chapter III Section 2.
  21. Annex IV section 2(g)The detailed description states the validation and testing procedures used. It gives information about the validation and testing data used and their main characteristics. It states the metrics used to measure accuracy, robustness, the other relevant requirements of Chapter III Section 2 and potentially discriminatory impacts. It includes the test logs and all test reports, dated and signed by the responsible persons, including with regard to the pre-determined changes under section 2(f).
  22. Annex IV section 2(h)The detailed description states the cybersecurity measures put in place.
  23. Annex IV section 3The documentation gives detailed information about the monitoring, functioning and control of the AI system. It states the capabilities and limitations in performance, including the degrees of accuracy for the specific persons or groups of persons on whom the system is intended to be used and the overall expected level of accuracy in relation to the intended purpose. It states the foreseeable unintended outcomes and the sources of risks to health and safety, fundamental rights and discrimination in view of the intended purpose. It states the human oversight measures needed in accordance with Art. 14, including the technical measures put in place to facilitate the interpretation of the outputs by the deployers. It gives specifications on input data, as appropriate.
  24. Annex IV section 4The documentation describes the appropriateness of the performance metrics for the specific AI system.
  25. Annex IV section 5The documentation gives a detailed description of the risk management system in accordance with Art. 9.
  26. Annex IV section 6The documentation describes the relevant changes made by the provider to the system through its lifecycle.
  27. Annex IV section 7The documentation lists the harmonised standards applied in full or in part whose references are published in the Official Journal of the European Union. Where no such harmonised standard is applied, the documentation gives a detailed description of the solutions adopted to meet the requirements of Chapter III Section 2, including a list of the other relevant standards and technical specifications applied.
  28. Annex IV section 8The documentation includes a copy of the EU declaration of conformity referred to in Art. 47.
  29. Annex IV section 9The documentation gives a detailed description of the system in place to evaluate the performance of the AI system in the post-market phase in accordance with Art. 72, including the post-market monitoring plan referred to in Art. 72(3).
  • The accuracy, robustness and other metric values declared in the documentation match the values in the dated and signed test reports it contains, for the same system version and the same test conditions (Annex IV section 2(g))
  • The degrees of accuracy stated for specific persons or groups of persons and the overall expected level of accuracy match the disaggregated and aggregate results in the test reports (Annex IV section 3)
  • The system version and the software or firmware versions stated in the general description match the deployed artefact and the versions named in the test reports (Annex IV section 1(a) and 1(c))
  • The architecture description matches the system as built: the listed components, their interfaces and the integrations with external hardware, software and other AI systems are present and no deployed component is missing from the description (Annex IV section 2(c) and 1(b))
  • The intended purpose and the conditions of use in the general description match the instructions for use and the promotional or sales materials (Annex IV section 1(a) and 1(h))
  • The datasheets match the data sets actually used: provenance, scope, main characteristics, labelling procedure and cleaning methodology as recorded in the data pipeline (Annex IV section 2(d))
  • The human oversight measures and the output interpretation measures described in the documentation are present in the system and in the instructions for use (Annex IV section 2(e) and section 3)
  • The cybersecurity measures described in the documentation are present in the deployed configuration (Annex IV section 2(h))
  • Every test log and test report in the documentation carries a date and the signature of a responsible person, and the set covers each pre-determined change described in section 2(f) (Annex IV section 2(g))
  • The lifecycle change record matches the version history in the general description and the versions covered by test reports (Annex IV section 6 with section 1(a) and 1(c))
  • Each entry in the standards and specifications list maps to the requirement it addresses, and each Chapter III Section 2 requirement without an applied harmonised standard maps to a described solution (Annex IV section 7)
  • The copy of the EU declaration of conformity names the same system, version and provider as the general description (Annex IV section 8 with section 1(a))
  • A technical documentation set exists that contains, at a minimum, the elements set out in Annex IV, in a clear and comprehensive form for national competent authorities and notified bodies (Art. 11(1))
  • For an SME, including a start-up, or an SMC that opts for the simplified manner, the documentation uses the Commission's simplified technical documentation form (Art. 11(1) third subparagraph)
  • For a system related to an Annex I Section A product, a single documentation set holds the Art. 11(1) information and the information required under the product legislation (Art. 11(2))
  • General description: intended purpose with context and conditions of use, provider name, system version and relation to previous versions, interaction with external hardware, software and other AI systems, software and firmware versions and update requirements, forms of placing on the market, target hardware, product photographs or illustrations where the system is a product component, and a basic description of the deployer user interface (Annex IV section 1(a) to 1(g))
  • Instructions for use for the deployer (Annex IV section 1(h))
  • Development methods and steps, including third-party pre-trained systems or tools and how they were used, integrated or modified (Annex IV section 2(a))
  • Design specifications: general logic, algorithms, key design choices with rationale and assumptions, classification choices, optimisation target and parameter relevance, expected output and output quality, and trade-off decisions taken to meet Chapter III Section 2 (Annex IV section 2(b))
  • Architecture description and the computational resources used to develop, train, test and validate the system (Annex IV section 2(c))
  • Datasheets for the training data sets with training methodologies and techniques, provenance, scope, main characteristics, acquisition and selection, labelling and cleaning (Annex IV section 2(d))
  • Assessment of the human oversight measures under Art. 14 and of the technical measures for output interpretation under Art. 13(3)(d) (Annex IV section 2(e))
  • Detailed description of pre-determined changes and the technical solutions that keep the system within Chapter III Section 2 (Annex IV section 2(f))
  • Description of the validation and testing procedures, the validation and testing data with their main characteristics, and the metrics used for accuracy, robustness, other Chapter III Section 2 requirements and potentially discriminatory impacts (Annex IV section 2(g))
  • Description of the cybersecurity measures put in place (Annex IV section 2(h))
  • Capabilities and limitations in performance, foreseeable unintended outcomes, sources of risk to health and safety, fundamental rights and discrimination, human oversight measures with output interpretation measures, and input data specifications (Annex IV section 3)
  • Description of the appropriateness of the performance metrics for the specific system (Annex IV section 4)
  • Detailed description of the risk management system under Art. 9 (Annex IV section 5)
  • List of the applied harmonised standards cited in the Official Journal, or, where none is applied, a detailed description of the solutions adopted and a list of the other standards and technical specifications applied (Annex IV section 7)
  • Copy of the EU declaration of conformity under Art. 47 (Annex IV section 8)
  • Detailed description of the post-market monitoring system under Art. 72, including the post-market monitoring plan under Art. 72(3) (Annex IV section 9)
  • The technical documentation is drawn up before the system is placed on the market or put into service (Art. 11(1))
  • The technical documentation is kept up to date over the lifecycle of the system (Art. 11(1))
  • Test logs and test reports are dated and signed by the responsible persons when they are produced, including for each pre-determined change (Annex IV section 2(g))
  • Relevant changes made to the system through its lifecycle are recorded as they occur (Annex IV section 6)

Metrics and where thresholds come from

Threshold sources, in order of precedence

  1. A harmonised standard cited in the Official Journal (none as of the anchor date)
  2. A JTC 21 draft standard (prEN), with its stage
  3. An ISO/IEC standard or technical report, with its stage
  4. A Commission guideline or code of practice, with its date from the standards data
  5. NIST AI RMF or a sector framework
  6. The state of the art, which the provider justifies and documents

Art. 11 and Annex IV set no numeric threshold. Annex IV section 2(g) and section 3 require the provider to state the metrics used and the degrees of accuracy; the values come from the provider's own testing under Art. 15. No harmonised standard is cited in the Official Journal of the European Union, so no presumption of conformity is available. The declaration structure today follows prEN 18229-2, a JTC 21 draft, which is hierarchy level 2. The provider justifies each declared value against the context of use and records that justification in the Annex IV section 4 statement on the appropriateness of the performance metrics; the PR-11-DOC consistency step that compares declared values with test reports records where each justification sits.

Metric sources and their stage
Source and stageTitleWhat it provides hereVerified on
prEN 18229-2DraftAI trustworthiness framework, part 2: accuracy and robustnessdraft declaration structure for accuracy and robustness levels and their metric categories, which sets the form in which Annex IV section 2(g), section 3 and section 4 state the metrics and the declared values

Verified on kla.digital, JTC 21 Standards Tracker (updated 29 June 2026)

prEN 18229-3DraftAI trustworthiness framework, part 3: transparency and human oversightdraft requirements for the information a provider gives deployers under Art. 13 and for the human-oversight measures under Art. 14, which sets the expected content of the instructions for use in Annex IV section 1(h) and the oversight descriptions in section 2(e) and section 3; at drafting stage, no text is public

Verified on kla.digital, JTC 21 standards tracker (29 June 2026)

prEN 18286PublishedQuality management system for EU AI Act regulatory purposes (approved as EN 18286:2026)the records, procedures and lifecycle controls of an Art. 17 quality management system, which give the documentation control, change recording and record-signing routines that keep the Annex IV set up to date under Art. 11(1) and section 6

Verified on CEN-CENELEC, EN in the spotlight: AI quality management (31 July 2026)

Procedures

Each protocol is versioned; its page states the derivation from the standards above. PR-11-DOC v1.0 assembles the set against the Annex IV headings and compares each declared value with the test report that supports it.

  • PR-11-DOC v1.0Annex IV documentation assembly and consistency protocolv1.0

What an assessor asks for

  • Annex IV technical documentation set (Annex IV sections 1 to 9)
  • Annex IV gap and consistency report (PR-11-DOC output)
  • Declared metric to test report consistency table (PR-11-DOC output)
  • Version and architecture reconciliation record (PR-11-DOC output)
  • Dated and signed test reports and test logs (Annex IV section 2(g))
  • Lifecycle change record (Annex IV section 6)
  • Standards and specifications list with requirement mapping (Annex IV section 7)
  • Simplified technical documentation form (Art. 11(1) third subparagraph)

Common findings

  • Accuracy is declared in the documentation as a single number while the test report gives a range under stated test conditions
  • The system version in the general description differs from the version in the test reports and from the deployed build
  • The architecture description reflects the design at project start and omits components and integrations added later
  • Test reports carry no date or signature, so the documentation cannot show which version the tests covered
  • The standards list names draft standards without their stage and without the requirement each one addresses
  • The lifecycle change record stops at the first release and does not cover retraining or configuration changes

Questions

What is Annex IV of the EU AI Act?

Annex IV lists the minimum content of the technical documentation that Art. 11(1) requires for a high-risk AI system. It has nine sections. Section 1 is a general description of the system. Section 2 is a detailed description of the elements and the development process. Section 3 covers monitoring, functioning and control. Section 4 describes the appropriateness of the performance metrics. Section 5 describes the risk management system under Art. 9. Section 6 records relevant changes through the lifecycle. Section 7 lists the standards and specifications applied. Section 8 is a copy of the EU declaration of conformity under Art. 47. Section 9 describes the post-market monitoring system under Art. 72.

What are the EU AI Act technical documentation requirements?

Art. 11(1) requires the provider to draw up the technical documentation before the system is placed on the market or put into service. Art. 11(1) requires the provider to keep it up to date. The documentation demonstrates that the system meets the requirements of Chapter III Section 2. It contains at least the elements in Annex IV. Art. 11(2) requires a single documentation set for a system related to an Annex I Section A product. SMEs, start-ups and SMCs may use the Commission's simplified form under Art. 11(1).

What does Article 11 of the AI Act require?

Art. 11 requires technical documentation for every high-risk AI system. The documentation exists before placing on the market or putting into service. The provider keeps it up to date. Its minimum content is set in Annex IV. National competent authorities and notified bodies use it to assess the system against Chapter III Section 2. Art. 11(3) lets the Commission amend Annex IV by delegated act under Art. 97.

What connects to Article 11 of the AI Act?

Annex IV sets the content of the Art. 11 documentation. Annex IV section 2(e) and section 3 draw on Art. 13 and Art. 14 for the instructions for use and the human oversight measures. Annex IV section 2(g) and section 3 draw on Art. 15 for the accuracy and robustness metrics. Annex IV section 5 draws on Art. 9 for the risk management system. Annex IV section 8 draws on Art. 47 for the EU declaration of conformity. Annex IV section 9 draws on Art. 72 for post-market monitoring. Art. 17(1)(k) places the record-keeping of the documentation inside the quality management system. Art. 18 requires the provider to keep the documentation at the disposal of the national competent authorities.

Is there an Annex IV technical documentation template?

Annex IV itself is the template: it fixes the sections and the sub-points the documentation must contain. No harmonised standard for documentation structure is cited in the Official Journal. prEN 18229-2, a draft, gives a structure for declaring accuracy and robustness levels that fits Annex IV section 2(g). Art. 11(1) provides a simplified form, established by the Commission, for SMEs, start-ups and SMCs. PR-11-DOC assembles the documentation against the Annex IV headings and checks each declared value against its test report.

What do Articles 11 and 12 of the EU AI Act require together?

Art. 11 requires the technical documentation that describes the system. Art. 12 requires the system to record events automatically over its lifetime. Annex IV section 3 describes the monitoring, functioning and control of the system, which includes the logging design. Annex IV section 2(g) includes the test logs from validation and testing. Art. 12 logs are operational records; Annex IV test logs are development records. Both must name the same system version.

How we test this

We review the technical documentation against the Annex IV headings and verify that each declared metric, version, architecture element and oversight measure matches the test reports, the deployed artefact and the instructions for use. We document each gap and each inconsistency with its Annex IV section reference.

What we cannot do

  • We do not perform conformity assessments where a notified body is required.
  • We do not issue CE marking or the EU Declaration of Conformity.
  • We are not a notified body.
  • We do not give legal opinions on classification or liability.
  • We test against requirements, prepare evidence, and structure documentation; compliance decisions remain with the provider or deployer, their notified body, and their counsel.

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