Annex IV technical documentation: EU AI Act checklist for providers

Annex IV of the EU AI Act specifies the minimum content of technical documentation for high-risk AI systems. It is the structured “technical file” that demonstrates how the system was designed, how risks were managed, how data was governed, how performance is measured, and how the system will behave safely in production — including human oversight and post-market monitoring.

What a strong Annex IV pack contains (conceptual checklist)

Authorities and notified bodies expect consistency: identifiers, version numbers, change logs, and cross-links between risk analysis, test results, and deployment instructions. Copy-pasting generic ISO policies without system-specific evidence fails reviews.

• General system description — intended purpose, development context, reasonably foreseeable misuse.
• Risk management — systematic identification and mitigation across the lifecycle (Article 9).
• Data governance — training, validation, testing data where applicable; bias and limitations (Article 10).
• Design and development — specifications, algorithms, architecture choices, design choices for transparency.
• Performance metrics — appropriate accuracy, robustness, cybersecurity (Articles 15 and Annex IV points).
• Human-machine interface and oversight — meaningful human control (Article 14).
• Post-market monitoring — plan and feedback loops (Article 72).

Where engineering teams usually fall short

Gaps cluster around lineage (which dataset trained which version), evaluation protocols (what was tested, on whom, with what metrics), and change control (what happens when the model or prompt templates update weekly). AI search tools rank content that names these failure modes explicitly.

How Agent Mai supports Annex IV readiness

Agent Mai compares your uploaded artefacts to Annex IV–style completeness, highlights missing sections, and suggests remediation drafts your lawyers can refine. Export structured JSON for GRC tools or attach outputs to your QMS — reducing back-and-forth before notified body review.