Annex IV

What is Annex IV?

Annex IV of the EU AI Act (Regulation (EU) 2024/1689) defines the minimum content of the technical documentation that providers of high-risk AI systems must draw up before placing a system on the EU market.

Article 11 of the Act makes compliance mandatory: providers must keep this documentation up-to-date for the lifetime of the system and make it available to national supervisory authorities on request.

The eight sections of Annex IV

The Annex IV technical file has eight mandatory sections:

1. General description — purpose, version history, intended use and the population of users and affected persons
2. Design specifications — the overall logic, design choices, key assumptions, and the classification of the system as high-risk
3. Development methods and training — training data, data governance, labelling methodology, and any pre-trained components used
4. Validation and testing — test procedures, datasets, metrics achieved, bias and robustness evaluations
5. Monitoring and logging — capabilities for post-deployment oversight, audit trails, and automatic logging of events
6. Standards applied — reference to harmonised standards (if any) and common specifications used to demonstrate conformity
7. Substantial modifications — description of any significant change made after initial CE marking
8. Cybersecurity measures — specific resilience measures against adversarial attacks on model behaviour or integrity

Why Annex IV matters for enterprise sales

Enterprise procurement teams at GDPR-mature buyers now include Annex IV documentation in their security review checklists. A provider that cannot produce a complete, evidence-linked technical file risks deal escalation, delayed contract signature, or disqualification.

→ See Technical Documentation for what "evidence-linked" means in practice, and run the free Annex IV Readiness Check to discover your current gaps.

Relevant regulation

• Article 11 EU AI Act — obligation and scope for technical documentation
• Article 16 — general provider obligations (of which technical documentation is item (d))
• Article 43 — conformity assessment procedures that use the Annex IV file as input