1. Introduction
Conformity based on assessment of the quality management system and technical documentation is based on points 2 to 5.
2. Overview
The quality management system for design, development and testing shall be examined in accordance with point 3 and subject to surveillance in point 5. Technical documentation shall be examined in accordance with point 4.
3. Quality management system
3.1. Application shall include:
(a) provider name and address
(b) list of AI systems covered
(c) technical documentation for each system
(d) quality management documentation per Article 17
(e) procedures for maintaining system adequacy
(f) declaration of no other application lodged
3.2. Assessment by notified body determining compliance with Article 17
3.3. Approved system shall be maintained
3.4. Changes must be reported to notified body
4. Control of technical documentation
4.1-4.7. Application, examination, access to data, further evidence requirements, conformity determination, certificate issuance, change assessment procedures
5. Surveillance of approved quality management system