Technical documentation (Annex IV)
Article 11 and Annex IV require providers of high-risk AI to draw up technical documentation before the system is placed on the market, describing the system, its development, performance, risk management and compliance — kept up to date.
Annex IV sets out what the file must contain: a general description of the system including its intended purpose and versions, a detailed description of its elements and development process including design choices, architecture, training methodologies and datasets, detailed information about monitoring, functioning and control including accuracy and foreseeable unintended outcomes, the risk-management system required by Article 9, a description of the lifecycle changes made, the harmonised standards applied or the technical solutions adopted instead, a copy of the EU declaration of conformity, and the post-market monitoring plan. SMEs including start-ups may supply the same information in a simplified form.
- Art. 11
- Art. 18
- Annex IV
Technical documentation (Annex IV): why it matters
The Annex IV file is the evidentiary backbone of the whole high-risk regime: the conformity assessment reviews it, the notified body reads it, the authorised representative holds it, and a market-surveillance authority requests it. It has to be drawn up before market placement and kept current for ten years afterwards, which makes it a maintained artefact rather than a launch deliverable. Its content also implies process: you cannot describe training methodologies and dataset provenance retrospectively if nobody recorded them at the time.
Technical documentation (Annex IV) in practice
A team preparing an Annex IV file discovers it can describe the current model precisely but cannot document why three features were dropped 18 months earlier, or which dataset version trained the model in production. The documentation gap is really a process gap, and the fix is upstream — model cards, dataset versioning and decision records generated as part of the development workflow rather than assembled by a compliance team at the end.
Technical documentation (Annex IV): the mistake people make
Treating the Annex IV file as a compliance document written after the product is finished. It has to describe design choices, assumptions and trade-offs made during development, which only exist if they were captured as they happened — and it must be kept up to date as the system changes, not frozen at launch.
Technical documentation (Annex IV): common questions
- When must Annex IV technical documentation be ready?
- Before the high-risk AI system is placed on the market or put into service, and it must be kept up to date thereafter. Providers must keep it at the disposal of national authorities for ten years after placing on the market.
- Is there a simplified form for SMEs?
- Yes. Article 11(1) allows SMEs including start-ups to provide the Annex IV elements in a simplified manner, using a form the Commission establishes. The information required is the same; the format is lighter.
- Who is allowed to see the technical documentation?
- National competent authorities and notified bodies on a reasoned request, and the authorised representative must have it available. It is not a public document — unlike the EU database registration, which carries a public subset.
Technical documentation (Annex IV): terms that come up alongside it
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