High-risk duties
Technical documentation (Article 11 & Annex IV)
What the technical documentation of a high-risk system must contain, when it must exist, and the simplified route available to SMEs.
Updated 3 July 2026 · Reference material, not legal advice
Technical documentation is the file that demonstrates a high-risk system meets the Act’s requirements. Under Article 11 it must be drawn up before the system is placed on the market and kept up to date, and provided to national authorities and notified bodies to assess conformity. Its minimum contents are set out in Annex IV.
What Annex IV requires
The documentation must include, at least:
- a general description of the system: intended purpose, provider, versions, how it interacts with hardware and software, and how it is placed on the market;
- a detailed description of the system and its development: design choices, architecture, data requirements (with datasheets on training methods and datasets), human-oversight measures, and validation and testing procedures with their metrics;
- information on monitoring, functioning and control — capabilities, limitations, accuracy for specific groups, foreseeable unintended outcomes and sources of risk;
- the appropriate performance metrics;
- a description of the risk-management system (Article 9);
- the changes made across the lifecycle;
- the harmonised standards applied, or the alternative solutions adopted;
- a copy of the EU declaration of conformity;
- the post-market monitoring plan (Article 72).
A single file for regulated products
Where a high-risk system relates to a product already covered by Union harmonisation legislation (Annex I, Section A), a single set of technical documentation is drawn up, combining the Annex IV elements with the information required under that sectoral law — avoiding duplication.
The SME route
Small and micro enterprises may provide the Annex IV elements in a simplified form. The Commission maintains a simplified template for that purpose, and notified bodies must accept it for the conformity assessment. This is one of several proportionality measures the Act includes for smaller organisations.
What this means in practice
Technical documentation is where much of the compliance evidence lives. Euridium organises the required elements against Annex IV and links each to the underlying obligation, so the file is a by-product of the work rather than a separate scramble before an audit.
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This guide is a plain-language summary for orientation. The authoritative text is Regulation (EU) 2024/1689 as published in the Official Journal of the European Union (12 July 2024). It does not constitute legal advice.