Article 11: technical documentation
The technical file demonstrating before market placement that a high-risk system meets the requirements.
The official source remains authoritative. This general interpretation is not legal advice.
- Status
- Upcoming
- Application date
- 2 December 2027
- Version
- 1.0.0
- Last reviewed
- 8 August 2026
Who this is relevant to
When this applies
Provider of an AI system
A party that develops or has an AI system developed and places it on the market under its own name.
- 1The provider places a high-risk AI system on the market or puts it into service.
What the official source establishes
Article 11 requires technical documentation drawn up before market placement, kept up to date and containing the Annex IV elements, so that compliance with Section 2 is demonstrable to supervisors.
For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.
Our interpretation
For buying organisations, Annex IV is the checklist of what you must be able to request contractually from your supplier; without that file you cannot meet your own Article 26 duties.
What you can do now
Include the right to access the technical documentation in AI procurement and supplier contracts now.
- 01
Build the technical file per Annex IV
Document system description, development process, data, oversight measures, performance and risk management before market placement.
What to retain
Technical file (Annex IV)
Technical documentation kept current per system version, ready for a supervisor’s request.
Control and reassessment
Documentation update on every release
Update the file before every release and retain earlier versions traceably.
Public tools
Full text of Article 11
The full legal text in the public AI Act Explorer.
Conditions and exceptions
- Small providers (SMEs) may provide the documentation in the simplified form established by the Commission.
Official sources and locators
EU Artificial Intelligence Act 2024/1689
European Parliament and Council | original-oj-2024-07-12
Source locator: Article 11(1)-(3) and Annex IV
Digital Omnibus on AI 2026/1744
European Parliament and Council | official-journal-2026-07-24
Source locator: Amended Article 113 application dates
Version history
v1.0.0
27 July 2026
Article 11: technical documentation
The technical file demonstrating before market placement that a high-risk system meets the requirements.
Execution
From obligation to arranged and demonstrable
Knowing where you stand is step one. Embed AI translates this obligation into a concrete approach for your organisation: scope, ownership, register and evidence.
See the Embed AI approachFor AI agents and integrations
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