Draw up technical documentation before placing a high-risk system on the market
Under EU AI Act, Article 11 and Annex IV
What does it require?
Technical documentation must be drawn up before a high-risk system is placed on the market or put into service and kept up to date. It must demonstrate compliance with the Section 2 requirements and contain at least the elements in Annex IV, including a general description, development process, monitoring and control, risk-management description, and the applied standards. SMEs may use a simplified form provided by the Commission.
Practical action
Maintain an Annex IV-structured technical file under version control.
Who does it apply to?
Providers of high-risk AI systems.
- Actors
- Provider / developer
- Sectors
- Cross-sector / all sectors
Applies from:
Evidence examples
- Annex IV technical file (document)
Framework mappings
Original editorial crosswalks. They cite clause numbers only and reproduce no standard text; confidence reflects how direct the mapping is.
| Framework | Reference | Note | Confidence |
|---|---|---|---|
| ISO/IEC 42001:2023 | Clause 7.5 Documented information; Annex A control on system documentation | Original editorial mapping. | high |
| NIST AI RMF 1.0 | GOVERN 1.4, MAP 3.x | Documentation practices. | medium |
Similar obligations in other instruments
- Developers must document high-risk systems and disclose known risks — Colorado AI Act, Colorado (United States)
Informational only, not legal advice. Verify every claim against the linked official sources and consult qualified counsel before acting.