Annex IV Technical Documentation, Explained Section by Section
Annex IV technical documentation is the master file for a high-risk AI system: Article 11 says you draw it up before the system reaches the market and keep it current afterwards. Annex IV then lists what goes in, nine numbered sections. Here is each one in plain English, with the evidence it expects.
The nine sections, decoded
| Annex IV section | What it wants, in practice |
|---|---|
| 1. General description | What the system does, intended purpose, who deploys it, hardware, versions |
| 2. Detailed description | Development process, design choices, architecture, training methodology |
| 3. Monitoring, functioning, control | How the system behaves in use, human oversight measures, foreseeable misuse |
| 4. Performance metrics | Why your accuracy metrics are appropriate for this purpose |
| 5. Risk management description | The Article 9 system: hazards found, mitigations chosen, residual risk |
| 6. Lifecycle changes | What changed since launch and how each change was assessed |
| 7. Standards applied | Harmonised standards used, or your alternative means of conformity |
| 8. Declaration of conformity | A copy of the signed Article 47 declaration |
| 9. Post-market monitoring plan | How you watch the system after deployment (Article 72) |
Two patterns make the work bearable. First, sections 1 through 4 are descriptions of facts you already know; the slow part is collecting them from engineering, product, and data teams. Second, sections 5, 6, and 9 are living documents, so wire them to a process, not a one-off writing sprint.
How we generate the file
AI Comply HQ's guided interview asks for the system facts once, in plain questions, and then drafts the Annex IV file alongside the rest of your tier's document set. You review, adjust, and export. The same facts also feed your risk register and oversight procedures, so the documents agree with each other. That consistency is exactly what an auditor reads for.
We also sell the Annex IV file as a one-time bundle for 350 dollars if you want the document without a subscription.
FAQ
Do SMEs get any relief?
Yes. Article 11 lets SMEs, including startups, provide the Annex IV elements in a simplified form, and the Commission is to provide a form for it. The content duties stay; the format lightens.
When does this bite?
Annex III high-risk obligations apply from 2 August 2026 under the current text. Documentation is the longest pole, so start with this file.
Sources
This page is informational content, not legal advice. Talk to a qualified lawyer about your specific situation.