Conformity Assessment — Third-Party Notified Body

Annex VII — Conformity Assessment Based on Assessment of Quality Management System and Assessment of Technical Documentation referred to in Article 43(3)

Section 1 — Introduction
This conformity assessment procedure for high-risk AI systems requires involvement of a notified body.

Section 2 — Quality management system
2.1 The provider's quality management system shall address: (a) strategy for regulatory compliance; (b) design and development procedures; (c) examination and testing procedures; (d) post-market monitoring procedures.

2.2 The notified body shall assess the quality management system. If satisfied, it issues a QMS certificate valid 5 years.

Section 3 — Surveillance of the approved quality management system
3.1 The notified body carries out periodic audits at least every 12 months.

Section 4 — Assessment of technical documentation
4.1 Applications to assess technical documentation shall include the technical documentation in Annex IV.
4.2 The notified body reviews the documentation and issues a technical documentation assessment certificate.