CA-001CriticalProviderPreventive
Conformity Assessment Pathway Selection
Article 43 requires providers to select the appropriate conformity assessment procedure for their high-risk AI system: internal control (Annex VI) under Article 43(2) for Annex III points 2 to 8, or third-party assessment by a notified body (Annex VII) under Article 43(1) for Annex III point 1 biometric systems where harmonised standards were not fully applied.
Articles:Article 43(1)Article 43(2)
Evidence Examples
- Conformity assessment pathway decision record
- Annex III category determination
- Notified body selection rationale
Standards
Annex VI EU AI ActAnnex VII EU AI Act
Related controls
- CA-002Internal Control Assessment (Annex VI)For AI systems subject to internal control assessment, providers must verify and document that the system meets all applicable requirements of Articles…
- CA-003Third-Party Notified Body AssessmentThird-party assessment is the exception. It applies to Annex III point 1 biometric identification and categorisation systems under Article 43(1) where…
- CA-004CE Marking AffixationArticle 48 requires that providers affix the CE marking to high-risk AI systems that have successfully completed conformity assessment, certifying that…
- CA-005EU Declaration of ConformityArticle 47 requires providers to draw up an EU Declaration of Conformity for each high-risk AI system, declaring that it meets all applicable…
- CA-006Notified Body Selection and EngagementWhere third-party assessment is required, providers must select a notified body that is duly designated for the relevant Annex III category, verify its…
- CA-007Conformity Re-Assessment TriggersArticle 43(4) requires providers to re-assess conformity when a substantial modification is made to the AI system, including changes that affect the…
Related EU AI Act terms
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