Anyone placing an AI system on the EU market under the AI Act will need technical documentation. For high-risk systems, Annex IV defines exactly what that documentation must contain. The good news: at heart, the annex is a structured checklist. The bad news: much of it cannot be produced on demand at the end — it has to be carried along across the whole lifecycle.
What Annex IV requires
Annex IV lists the components of the technical documentation. Simplified, they fall into six blocks:
- General description of the system: intended purpose, responsible parties, versions, interaction with hardware and software.
- Detailed technical description: development steps, system architecture, compute resources, data requirements and the design choices made.
- Data governance: origin, preparation, assumptions and known biases of the training, validation and test data.
- Monitoring, functioning and control: accuracy, robustness, metrics and the limits of the system.
- Risk management: the system established under Article 9 and the measures taken.
- Changes and conformity: lifecycle changes, standards applied and the EU declaration of conformity.
Why readiness starts early
The classic mistake is to treat documentation as a closing act. In practice, data provenance, design rationale or test results can rarely be reconstructed cleanly after the fact. Teams that instead adopt the Annex IV structure early — as their working outline — capture evidence where it is created: inside the development process itself.
In concrete terms, that means a living document rather than a point-in-time report. Every relevant decision — an architecture choice, a rejected dataset, a re-tuned threshold — is recorded together with its rationale. It is exactly this chain of reasoning that later makes a conformity assessment traceable.
A pragmatic sequence
For teams without a dedicated compliance office, a lean order of work tends to hold up:
- First, pin down the intended purpose precisely — it drives almost everything else.
- Then document the data basis while the sources are still fresh and at hand.
- In parallel, set up risk management and let it run alongside development.
- Only at the end, bring together the cross-cutting artefacts — metrics, declaration of conformity, references to standards.
Where GARION fits in
GARION maps the Annex IV structure as a readiness domain: it walks you through the required blocks, records decisions with their rationale, and shows the working status per section. The output is not a conformity verdict but an ordered, auditable state of preparation — the basis on which professionals carry out the actual assessment.
Note: GARION supports preparation for the EU AI Act and related frameworks. GARION is not a substitute for legal advice, conformity assessment or certification.