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Risk level: high Title Annexes

Annex VI — Conformity Assessment Procedure (Internal Control)

Conformity assessment procedure based on internal control 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...

ANNEX VI
Conformity assessment procedure based on internal control
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.
ELI: http://data.europa.eu/eli/reg/2024/1689/oj 133/144
EN OJ L, 12.7.2024

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