Annex IV Technical Documentation, Explained Section By Section

Drew & AI Comply HQ™ Team · May 30, 2026

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.

FAQ

Do SMEs get any relief?

Yes. Article 11 lets SMEs, including startups, provide the Annex IV elements in a simplified form. A July 2026 change to the law lets small mid-cap companies (SMCs) use it too. The Commission is to provide the form. What you must cover stays the same. Only the format gets lighter.

When does this bite?

Annex III high-risk duties apply from December 2, 2027. AI built into regulated products under Annex I, Section A, like medical devices, follows on August 2, 2028. Both dates come from the Digital Omnibus on AI (Regulation (EU) 2026/1744), which moved them in July 2026. Machinery, vehicles, and other Section B products get their AI rules through their own EU laws (Article 2(2)). Documentation takes the longest, so start with this file.

Generate your Annex IV draft

Sources

This page is informational content, not legal advice. Talk to a qualified lawyer about your specific situation.