EU AI Act Art. 11 — Technical documentation
Article 11 requires providers to draw up and keep technical documentation before placing a high-risk system on the market. It must prove compliance to authorities — Annex IV sets out exactly what goes in it.
At a glance
What this article requires
- Technical documentation must be drawn up before market placement and kept up to date.
- It must demonstrate compliance and give authorities enough to assess it.
- Annex IV lists the minimum contents: system description, design specs, data governance, risk management, testing, and instructions for use.
- Authorities can request it during market surveillance or conformity assessment.
- It pairs with record-keeping (Art. 12) and the quality management system (Art. 17).
Scope
Who this applies to
Providers of high-risk AI systems — including providers of foundation models downstream, who may need to leverage upstream documentation.
Obligations
What you must actually do
Prepare before launch
Documentation is a precondition for market placement, not a post-launch chore. It feeds the conformity assessment and CE marking under Article 43–48.
Follow the Annex IV skeleton
Cover: general system description and intended purpose, architecture and development process, data and training methodology, performance and testing results, risk management outputs, and instructions for use.
Keep it current
Substantial changes (model swaps, new data pipelines, new intended purposes) require updating the documentation — and often re-running conformity assessment.
Action plan
Practical first steps
- 1
Adopt an Annex IV checklist and draft the documentation in parallel with development, not after.
- 2
Store it in a controlled system with version history and access audit.
- 3
Map each Annex IV item to its evidence (test reports, data sheets, risk register entries).
- 4
Review after every release that changes the system's intended purpose or core model.
Penalty exposure
Missing or inadequate technical documentation is penalised in the general tier: up to €15 million or 3% of global annual turnover.
FAQ
Questions about Art. 11
Who reads my technical documentation?
Notified bodies during third-party conformity assessment (Annex I systems), and market surveillance authorities during checks. Deployers may also ask for it during procurement due diligence.
Is my documentation confidential?
Yes — authorities must respect business confidentiality, but they can require access as needed to verify compliance. Keep it complete; redaction is not a strategy.
Sources
Citations & further reading
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Check my use casePreliminary EU AI Act clarity summary. Not legal advice.