Technical documentation and Annex IV: what a high-risk AI system’s paper trail must include (Article 11)
In short
Technical documentation is the single artefact a market surveillance authority is most likely to request first, and its absence or incompleteness is treated as a standalone compliance failure regardless of how well the system actually performs. Article 11 requires it to be drawn up before the system is placed on the market or put into service, it cannot be reconstructed retroactively once a regulator asks for it.
What Annex IV requires
At minimum, the documentation must cover:
- A general description of the system: intended purpose, provider details, and how it interacts with hardware or software.
- The development process and design specifications: general logic, key design choices and their rationale, and (where relevant) use of pre-trained systems or third-party tools.
- Data requirements: datasets used, their provenance, scope, and labelling procedures.
- Monitoring, functioning, and control information: capabilities, limitations, accuracy metrics, and foreseeable unintended outcomes.
- Validation and testing procedures, including the results.
- A reference to the Article 9 risk management system.
- The standards applied and, where relevant, the conformity assessment procedure followed.
A simplified form exists for smaller companies
Article 11(1) allows SMEs and micro-enterprises to use a simplified technical documentation form the Commission is required to establish. Notified bodies are obliged to accept it, but the simplified form still has to cover the same substantive Annex IV elements in a lighter format, not a reduced substantive scope.
Living documentation, not a launch artefact
Because the technical documentation must be kept up to date throughout the system’s lifecycle, a change to the model, the training data, or the intended purpose that is not reflected in the documentation is itself a compliance gap, even if the underlying system continues to function correctly. This is the most common way technical documentation quietly goes out of date: teams update the system without a parallel process to update the paperwork.
Relationship to the EU declaration of conformity
Technical documentation is the substantive evidence base the EU declaration of conformity (Article 47) formally attests to, the declaration is a short, signed statement; the technical documentation is what a regulator actually reviews to test whether that statement holds up. The two are drawn up separately but should never contradict one another.
Because this is a provider obligation, deployers do not draw up their own technical documentation, but a deployer relying on a vendor-supplied high-risk system should confirm it exists and can be produced on request, since a missing or incomplete Annex IV file is a risk signal about the vendor’s overall conformity posture, not just a paperwork gap.
Frequently asked questions
- When must technical documentation be created under Article 11?
- Before the high-risk system is placed on the market or put into service, and it must be kept up to date throughout the system's lifecycle. It cannot be reconstructed retroactively once a regulator asks for it.
- What must Annex IV technical documentation cover?
- At minimum: a general description of the system and its intended purpose; the development process and key design choices; data requirements and provenance; monitoring, accuracy metrics, capabilities and limitations; validation and testing procedures and results; a reference to the Article 9 risk management system; and the standards and conformity assessment procedure applied.
- Do small companies get a lighter technical-documentation form?
- Yes. Article 11(1) lets SMEs and micro-enterprises use a simplified technical-documentation form that notified bodies must accept, but it still has to cover the same substantive Annex IV elements in a lighter format, not a reduced substantive scope.
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