Annex IV Technical Documentation: Structure, Template & Examples

1) A general description of the system — intended purpose, provider, version, hardware requirements, market form, and instructions for use. 2) A detailed description of elements and development process — design specs, architecture, data requirements and provenance, human oversight measures, and pre-determined changes. 3) Monitoring, functioning and control details — capabilities, limitations, foreseeable misuse, input data specifications. 4) Performance metrics and their appropriateness. 5) The risk management system per Article 9. 6) Lifecycle changes description. 7) Applied harmonised standards or alternative solutions. 8) A copy of the EU declaration of conformity. 9) The post-market monitoring plan per Article 72.

Section 2 is the workhorse and the usual bottleneck — most teams have never written down their data provenance, labelling methodology or oversight design in one place. Expect this section alone to surface gaps you then have to close (which is partly the point).

Section 4 trips up teams who report only aggregate accuracy. The Act expects metrics appropriate to the system's purpose — for a hiring tool, that means performance across demographic groups, not one blended number.

The technical documentation should exist before conformity assessment. Some downstream fields, such as the EU declaration of conformity details and live post-market monitoring evidence, may remain placeholders in a first draft until those steps exist.

Yes — the structure is public and no law says a lawyer must write it. What you need is discipline about completeness (every heading answered, gaps marked as gaps) and enough regulatory reading to use the right vocabulary. Budget 2–4 weeks of senior-engineer-plus-founder time for a first credible draft.

The shortcut is starting from a completed structure instead of a blank page: a template pre-filled from a questionnaire gives you the skeleton, the article references, and company-specific evidence gaps clearly marked, leaving your team the parts only you can know — metrics, data specifics, test results.

Article 11(1) lets SMEs, including startups, provide the Annex IV elements in a simplified form; the Commission is mandated to provide a simplified template. Simplified does not mean skippable — every element still needs an answer — but the depth expectation scales with company size.