Article 11 of the EU AI Act: Technical Documentation (Annex IV)
Article 11 requires the Annex IV technical documentation — the evidentiary backbone that proves a high-risk system conforms — to be drawn up before the system is placed on the market and kept up to date.
What Article 11 requires
The documentation must contain, at minimum: a general description of the system; its development process and design; monitoring, functioning and control details; the risk-management system; changes over the lifecycle; standards applied; and the EU declaration of conformity. Microenterprises and small companies may use a simplified form.
Who it binds
Providers of high-risk AI systems. Importers and distributors verify this documentation exists before placing the system on the market.
Key points
- Must exist before market and be kept current.
- Annex IV lists the required contents.
- SMEs may use a simplified documentation form.
FAQ
What goes in Annex IV documentation?
A general system description, development and design details, monitoring and control information, the risk-management system, lifecycle changes, standards applied, and the declaration of conformity.
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