Conformity Assessment Procedure Based on Internal Control
Self-assessment route for providers of high-risk AI systems
Overview
Defines the self-assessment route for providers of high-risk AI systems that do not require third-party (notified body) involvement. This is the simpler of the two conformity assessment paths.
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 .
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 is consistent with the technical documentation.
