EU AI Act glossary
Technical Documentation (EU AI Act)
Technical documentation is the mandatory regulatory dossier that high-risk AI providers must compile under EU AI Act Article 11 and Annex IV. It proves conformity to a notified body or supervisory authority.
Last updated 17 June 2026
Definition
Technical documentation, in the context of the EU AI Act, refers to the structured file that providers of high-risk AI systems must compile prior to placing a system on the EU market. Its content is defined by Annex IV and its obligation is stated in Article 11.
The document is not a marketing brief or a slide deck. It is a regulatory dossier — equivalent in purpose to the technical file required under the Medical Devices Regulation — that a notified body or national market surveillance authority can audit.
What makes documentation "evidence-linked"?
Every claim in the technical file must be traceable to a verifiable artefact:
| Claim | Assertion-based (weak) | Evidence-linked (strong) |
|---|---|---|
| "We validate before deployment" | Free-text declaration | Link to MLflow experiment run with metrics |
| "Training data is representative" | Checkbox on a questionnaire | Data sheet + bias audit report with p-values |
| "Monitoring is in place" | "Yes, we monitor the system" | Link to live Grafana dashboard + alert policy |
Enterprise security reviewers — particularly at regulated buyers in financial services and healthcare — are trained to reject assertion-based files. Evidence-linked documentation is what closes deals.
Lifecycle obligations
Technical documentation is not a one-time exercise. Article 11 requires it to be:
- Accurate at the time of placing on the market or putting into service
- Updated whenever the system undergoes a substantial modification
- Retained for ten years after the system is placed on the market
- Available to competent authorities on request within a reasonable timeframe
Relationship to conformity assessment
For most high-risk AI systems, the conformity assessment procedure (Article 43) requires the provider to demonstrate that the technical file is complete and accurate. Some categories — particularly biometric identification systems — require a notified body to examine the file independently.
→ Run the free Annex IV Readiness Check to see how complete your current file is, or read the complete requirements breakdown.
Check your Annex IV coverage
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