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Annex VI

Conformity Assessment Procedure Based on Internal Control

Updated on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

1. The conformity assessment procedure based on internal control is the conformity assessment procedure based on points 2, 3 and 4.

2. The provider verifies that the established quality management system is in compliance with the requirements of Article 17.

3. The provider examines the information contained in the technical documentation in order to assess the compliance of the AI system with the relevant essential requirements set out in Chapter III, Section 2.

4. The provider also verifies that the design and development process of the AI system and its post-market monitoring as referred to in Article 72 is consistent with the technical documentation

[Previous version]

Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

1. The conformity assessment procedure based on internal control is the conformity assessment procedure based on points 2 to 4.

2. The provider verifies that the established quality management system is in compliance with the requirements of Article 17.

3. The provider examines the information contained in the technical documentation in order to assess the compliance of the AI system with the relevant essential requirements set out in Chapter III, Section 2.

4. The provider also verifies that the design and development process of the AI system and its post-market monitoring as referred to in Article 72 is consistent with the technical documentation.

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

1. The conformity assessment procedure based on internal control is the conformity assessment procedure based on points 2 to 4.

2. The provider verifies that the established quality management system is in compliance with the requirements of Article 17.

3. The provider examines the information contained in the technical documentation in order to assess the compliance of the AI system with the relevant essential requirements set out in Title III, Chapter 2.

4. The provider also verifies that the design and development process of the AI system and its post-market monitoring as referred to in Article 61 is consistent with the technical documentation.

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