Conformity Assessment Procedure — Internal Control

Annex VI — Conformity Assessment Procedure Based on Internal Control referred to in Article 43(2)

1. The conformity assessment procedure based on internal control is the conformity assessment procedure whereby the provider fulfils the obligations set out in points 2, 3 and 4, and ensures and declares on its sole responsibility that the high-risk AI systems concerned satisfy the requirements of this Regulation.

2. Technical documentation: The provider shall establish the technical documentation in accordance with Annex IV.

3. Quality management system: The provider shall implement a quality management system in accordance with Article 17.

4. Documentation conservation: The provider shall keep the documentation for a period of 10 years after the AI system has been placed on the market or put into service.

5. The provider or, where established in a third country, its authorised representative shall keep a copy of the EU declaration of conformity at the disposal of the national competent authorities for 10 years.