EU AI Act Article 11 + Annex IV — Technical documentation
Technical documentation must be drawn up before a high-risk AI system is placed on market, demonstrating compliance with all requirements and kept up to date
Where this comes from
Provision: Article 11 + Annex IV — Technical documentation
Instrument: EU Artificial Intelligence Act (Regulation (EU) 2024/1689)
Citation: Article 11 + Annex IV, Regulation (EU) 2024/1689
Text version: Regulation (EU) 2024/1689 (AI Act), OJ L, 12.7.2024
Who it applies to
High-risk AI provider in scope — all of these:
- Service deploys AI systems in a professional capacity
- AI Act role is Provider or we provide some AI systems and deploy others
Annex III high-risk area (Art. 6(2)) — any one of these:
- Annex III high-risk areas includes Biometrics
- Annex III high-risk areas includes Critical infrastructure
- Annex III high-risk areas includes Education and vocational training
- Annex III high-risk areas includes Employment and worker management
- Annex III high-risk areas includes Essential public services
- Annex III high-risk areas includes Creditworthiness
- Annex III high-risk areas includes Insurance
- Annex III high-risk areas includes Law enforcement
- Annex III high-risk areas includes Migration, asylum and border control
- Annex III high-risk areas includes Administration of justice and democratic processes
…unless:
- AI Act scope exclusion is used exclusively for military, defence or national-security purposes or developed and used solely for scientific research and development
- Art. 2(3): the Regulation 'does not apply to AI systems where and in so far as they are placed on the market, put into service, or used with or without modification exclusively for military, defence or national security purposes'. (AI Act Art. 2(3))
- Art. 2(6): the Regulation 'does not apply to AI systems or AI models, including their output, specifically developed and put into service for the sole purpose of scientific research and development'. (AI Act Art. 2(6))
- Art. 6(3): an Annex III system is NOT high-risk where it does not pose a significant risk of harm to health, safety or fundamental rights, including by not materially influencing the outcome of decision making — which applies where the system (a) performs... (AI Act Art. 6(3))
- Art. 11(1), third subparagraph: a provider that is a micro or small enterprise may supply the Annex IV elements in the simplified form set out in the template the Commission is to establish. (AI Act Art. 11(1), third subparagraph)
Scope in the source's own terms
- Art. 2(1): the AI system is placed on the market or put into service in the Union, or the provider/deployer is established in the Union, or the output produced by the system is used in the Union
- Art. 6(2): the AI system falls within an area listed in Annex III and is therefore high-risk, no documented Art. 6(3) derogation applying (and it is ALWAYS high-risk where it performs profiling of natural persons)
- Art. 16(a) ('Providers of high-risk AI systems shall …'), read with Art. 3(3): the actor develops the system or has it developed and places it on the market or puts it into service under its own name or trade mark — or is its authorised representative under Art. 22
What engineering work it implies
- Annex IV Technical Documentation as CodeCovers it fully
A /docs/ai-system/ skeleton carrying the nine Annex IV sections, versioned with the code, plus a CI check that fails the build when a model version changes without a...
Sample acceptance criteria Landfall generates for this obligation:
- Every required section of the referenced annex/standard exists as its own addressable document (an empty section is visible, a missing one fails)
- A machine-readable manifest records the documented version and the documentation revision it corresponds to
- An automated check fails when the documented version changes and no section was updated with it
- Each document records an owner and the date and person of its last review — a review date with no reviewer is rejected
- A dated snapshot is archived on each release so the version that applied on any past date can be produced
Evidence an auditor expects
- Policy documentDocument reviewRetain Art. 18(1): 10 years after the system is placed on the market or put into serviceReviewed kept up to date; reviewed on each substantial modification
Annex IV technical documentation for the high-risk AI system
Documentation drawn up BEFORE the system is placed on the market or put into service and kept up to date, containing at minimum the Annex IV elements: general description of the system; detailed description of its elements and development process; monitoring, functioning and control information; the Art. 9 risk management system; changes made through the lifecycle; the list of harmonised standards applied; the EU declaration of conformity; and the Art. 72 post-market monitoring plan. It must demonstrate compliance with Chapter III Section 2 and give national competent authorities and notified bodies the information needed to assess it
- Process recordDocument review
Version and change history of the technical documentation
Change log tying each documentation version to the system version it describes, so the state of the documentation at any past date can be reconstructed for an authority
Questions people ask
- Does EU AI Act Article 11 + Annex IV — Technical documentation apply to my service?
- It applies when Service deploys AI systems in a professional capacity; AI Act role is Provider or we provide some AI systems and deploy others; and at least one of: Annex III high-risk areas includes Biometrics; Annex III high-risk areas includes Critical infrastructure; Annex III high-risk areas includes Education and vocational training; Annex III high-risk areas includes Employment and worker management; Annex III high-risk areas includes Essential public services; Annex III high-risk areas includes Creditworthiness; Annex III high-risk areas includes Insurance; Annex III high-risk areas includes Law enforcement; Annex III high-risk areas includes Migration, asylum and border control; Annex III high-risk areas includes Administration of justice and democratic processes. It does not apply where AI Act scope exclusion is used exclusively for military, defence or national-security purposes or developed and used solely for scientific research and development.
- When does this become enforceable?
- EU AI Act Article 11 + Annex IV — Technical documentation is enforceable from 2 August 2026. Its current status is: in force.
- What evidence does an auditor expect?
- Annex IV technical documentation for the high-risk AI system; Version and change history of the technical documentation.
Find out whether this one lands on you
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Not legal advice. Landfall maps regulatory obligations to engineering work for planning purposes. Its verdicts are not legal advice and create no attorney-client relationship — verify with qualified counsel before relying on them.