Draw up technical documentation before placing a high-risk system on the market
EU AI Act · Article 11 and Annex IV
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.
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Applies from 2 Aug 2026