Annex VII establishes a five-point sequence running from initial application through ongoing surveillance. The organisation maps each Annex VII point to the corresponding AISDP section, responsible role, and evidence artefact.

Point 2 provides the overview: QMS examined per point 3, technical documentation per point 4. Points 3.1 through 3.4 cover the QMS assessment: application contents, NB assessment against Article 17, approved QMS maintenance, and change notification. Points 4.1 through 4.7 cover the technical documentation assessment: separate application per system, application contents, NB examination with dataset access, supplementary evidence requests, model access with IP protections, certificate issuance, and change assessment. Points 5.1 through 5.3 cover ongoing surveillance: QMS compliance verification, premises access, periodic audits.

For Annex I product AI systems, Article 43(3) specifies that points 4.3, 4.4, 4.5, and the fifth paragraph of point 4.6 apply even where the conformity assessment is conducted as part of the product-level assessment. The Conformity Assessment Coordinator flags these points to the product notified body.

Key outputs

• Per-point Annex VII mapping to AISDP sections and evidence
• Responsible role identification per requirement
• Annex I product integration flagging
• Assessment preparation documentation