Annex IV Documentation Overview

The technical file every high-risk system must have.

Annex IV is the EU AI Act's specification for technical documentation — the file a regulator or notified body will ask for first. For high-risk systems it's mandatory before market entry (Art. 11).

What Annex IV requires

A complete file covers, in substance:

  1. A general description of the system — purpose, provider, versions, hardware, how it interacts with its environment.
  2. A detailed technical description — development process, architecture, training data and its provenance, labelling, cleaning.
  3. Monitoring, functioning, and control — what users see, human oversight measures, expected lifetime.
  4. Performance metrics — accuracy, robustness, cybersecurity, and known limitations.
  5. The risk management system (Art. 9).
  6. Lifecycle changes and versioning.
  7. Standards applied (harmonised standards or your own solutions).
  8. A copy of the Declaration of Conformity.
  9. The post-market monitoring plan (Art. 72).

How the generator works

Open Dashboard → Annex IV. The generator interviews you section by section, pre-fills what it already knows (your classification, scanner findings), and lets AI-assisted drafting propose text you review and edit. Export the result as a professional PDF.

Quota

Free includes 1 Annex IV document per month; Starter and above are unlimited. During your trial you have the Pro allowance.

One file per AI system — not one per company. Keep it versioned as the system evolves.

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Guardia AI provides compliance tooling, not legal advice. For official regulatory text, see EU Regulation 2024/1689.