Draw up & maintain the Annex IV technical file
Draw up the Annex IV technical documentation before market placement and keep it up to date as a living document; it is the primary evidence package assessed at conformity assessment.
- Applies to
- Provider
- Applies from
- 2027-12-02 — Stand-alone high-risk (Annex III) obligations apply
- Derives from
- Article 11 · Annex IV
- Primary source
- Art. 11 AIA · Annex IV AIA
Evidence an auditor expects
- Annex IV technical file — The full technical documentation package; primary evidence at conformity assessment; must be a living, versioned document.
- Requirement-to-evidence compliance matrix — A matrix mapping each Annex IV requirement to the specific document/section/evidence that satisfies it. Explicitly what auditors ask for.
Audit red flags
Fails an audit
- Documentation created after the fact rather than contemporaneously with the decision — national competent authorities apply the contemporaneous standard.
- No clear version control / traceability between document versions and system versions.
- No compliance matrix mapping each requirement to the specific evidence that satisfies it.
Common mistakes
- Assembling the technical file just before assessment.
Fix: Maintain it as a living document from development onward; contemporaneous records are the standard.
FAQ
What evidence do I need for Article 11?
Annex IV technical file, Requirement-to-evidence compliance matrix. Each should be contemporaneous, versioned, and traceable to the system version.
When does “Draw up & maintain the Annex IV technical file” apply?
From 2027-12-02 — Stand-alone high-risk (Annex III) obligations apply. It applies to: Provider.
What fails an audit here?
Documentation created after the fact rather than contemporaneously with the decision — national competent authorities apply the contemporaneous standard.; No clear version control / traceability between document versions and system versions.; No compliance matrix mapping each requirement to the specific evidence that satisfies it.
Legal source
Explained in the newsletter
Stay audit-ready as the Act changes
EU AI Regulation Decoded tracks each obligation and the evidence auditors expect — one practitioner email a week.
Subscribe — free, weeklyNot legal advice. This is a practitioner reference generated from a cited knowledge base built on the primary legal text and official Commission guidance. Verify against the cited primary sources before relying on it for a compliance decision. See editorial standards & methodology.