Annex IV of the EU AI Act sets out the technical documentation a high-risk AI system must carry: a general description of the system and its intended purpose, how it was developed and tested, its data and data-governance choices, its risk-management measures, human oversight and control, performance metrics and known limitations, and how changes are tracked over its lifetime. It has to exist before the system is placed on the market and stay current afterwards. The practical test is completeness: a partially documented high-risk system is a compliance failure regardless of how well the system itself behaves.
Why the documentation exists
Once a system is classified as high-risk under the EU AI Act, the provider must draw up and keep technical documentation before the system goes to market, and keep it current thereafter. It's the artefact a regulator or notified body reads to judge whether the system genuinely meets the Act's requirements. Annex IV sets out what it has to contain — and because it must be complete before the system is placed on the market, a gap in it is a gap in your compliance.
What Annex IV broadly covers
The Annex IV set walks from what the system is to how it's watched over its life:
| Area | What it documents |
|---|---|
| General description | What the system is, its intended purpose, who provides it, and how it interacts with hardware and software. |
| Development & design | The elements of the system and the process behind it — design choices, the data used, and the logic. |
| Data governance | The training, validation and testing data — its provenance, characteristics and preparation. |
| Monitoring & control | Capabilities and limitations, accuracy and robustness, and the human oversight measures in place. |
| Risk management | The risk-management system and the risks identified and mitigated. |
| Changes & standards | Changes made over the system's lifecycle, and the harmonised standards applied. |
| Conformity & post-market | The EU declaration of conformity and the post-market monitoring plan. |
The exact structure is set out in the Annex itself; treat the above as the shape of it, and confirm the current text for your system.
Completeness is the gate
The subtle thing about technical documentation is that its value is binary at the section level. A risk-management system that's thorough on data but silent on human oversight isn't 90% compliant — it has a missing section, and that's what an assessor finds first. The discipline is therefore less about writing beautifully and more about ensuring every required area is actually present and current for every high-risk system you run.
Whether the documentation is complete is checkable: for each high-risk system, is each required Annex IV area present? Running that as a gate — rather than trusting that "the documentation exists somewhere" — is what turns a pile of documents into defensible evidence.
Keeping it current
Technical documentation isn't a launch artefact you file and forget. Systems change, data is refreshed, risks evolve — and the documentation has to move with them. A record that was complete at launch and never touched again drifts out of date, and a serious-incident investigation is the worst time to discover it.
How Qgentic keeps the record ready
Qgentic AI Act runs the Annex IV completeness gates for each high-risk system as it assembles your register, and reports exactly which areas are present and which are missing — so the documentation obligation is a live checklist. It sits on the same approval gate and audit trail as the rest of the platform, and is prepare-only: EU-database registration and conformity assessment run through your own provider channels.
This is engineering-and-compliance orientation, not legal advice; Annex IV's exact contents and the Act's timelines are defined in the Regulation and phase in over time. Confirm the current requirements for your systems with counsel.
Qgentic runs the Annex IV completeness gates for every high-risk system and shows exactly what's missing.
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