Annex IV: Technical Documentation for High-Risk AI Systems

Annex IV is the structured checklist behind Article 11. It converts the abstract duty to "draw up technical documentation" into concrete headings the provider must address. The documentation must contain at minimum:

1. General description of the AI system (intended purpose, interaction with hardware/software, versions, forms of distribution) 2. Detailed description of the development process including design, architecture, data, training/testing/validation, key design choices and rationale 3. Detailed information about monitoring, functioning, and control including capabilities, limitations, foreseeable misuse, human oversight measures, computational and hardware requirements 4. Description of the risk management system as per Article 9 5. Description of changes made through the system's lifecycle 6. List of harmonised standards applied (or other solutions chosen where standards are not followed) 7. Copy of the EU declaration of conformity (Article 47) 8. Description of the post-market monitoring system under Article 72

Always read the exact sub-points under each heading on EUR-Lex—this summary is not exhaustive.

Teams often confuse these two annexes:

• Annex IV = documentation for high-risk AI systems (the downstream product/application), required by Article 11.
• Annex XI = documentation for GPAI models (the upstream foundation model), required by Article 53(1)(a).

If your high-risk system integrates a GPAI model, both annexes apply at different layers: the GPAI provider produces Annex XI documentation, and the high-risk system provider produces Annex IV documentation (using Article 53(1)(b) downstream information from the GPAI provider to populate relevant sections).

• Article 11 — The direct legal hook requiring Annex IV content.
• Article 9 — Risk management outputs feed Annex IV point 4.
• Article 10 — Data governance decisions feed Annex IV development process sections.
• Article 12 — Logging design must align with what Annex IV promises.
• Article 13 — Instructions for use must be consistent with Annex IV.
• Article 14 — Oversight measures documented in Annex IV.
• Article 15 — Accuracy, robustness, cybersecurity metrics in Annex IV.
• Article 43 — Conformity assessment relies on Annex IV.
• Article 47 — EU declaration of conformity (included in Annex IV).
• Article 72 — Post-market monitoring plan in Annex IV.
• Article 97 — Delegated acts may update Annex IV.
• Annex XI — GPAI model documentation (the upstream counterpart).

The recitals in the same consolidated AI Act on EUR-Lex contextualise technical documentation, conformity assessment, and SME proportionality. Use the official preamble on EUR-Lex—do not rely on unofficial recital lists without checking sequence and wording against the authentic text.