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Annex IV

Technical Documentation for High-Risk AI Systems

Plain-Language Summary

Specifies the content required in the technical documentation that providers of high-risk AI systems must draw up before placing them on the market (Article 11).

Keywords

technical documentationhigh-riskprovider obligationsArticle 11training datarisk management

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Annex IV — Technical Documentation referred to in Article 11(1)

The technical documentation referred to in Article 11(1) shall contain at least the following information:

1. A general description of the AI system including:
   (a) its intended purpose;
   (b) the version of the software;
   (c) how it interacts with hardware/software;
   (d) descriptions of each system version and updates.

2. A detailed description of the elements of the AI system including:
   (a) training methods and techniques;
   (b) model architecture and design choices;
   (c) training data and datasets used;
   (d) data governance and management practices;
   (e) assessment of available training, validation and testing data.

3. Detailed information about the monitoring, functioning and control of the AI system.

4. A description of the risk management system in accordance with Article 9.

5. Changes made to the system through its lifecycle.

6. A list of the harmonised standards applied.

7. Copy of the EU declaration of conformity.