Compliance & AssessmentArticle 3(20)Article 43
Conformity Assessment
The process of verifying whether a high-risk AI system complies with the requirements set out in Chapter III Section 2 of the Regulation. Can be conducted through internal control (Annex VI) or with involvement of a notified body (Annex VII).
Related terms
- CE MarkingThe marking by which a provider indicates that a high-risk AI system is in conformity with the requirements set out in Chapter III Section 2 of the…
- EU Declaration of ConformityA statement made by the provider affirming that a high-risk AI system is in conformity with the provisions of the Regulation and all applicable Union…
- Fundamental Rights Impact AssessmentA structured assessment required under Article 27 for deployers of high-risk AI systems that are bodies governed by public law, or private operators…
- Quality Management SystemA documented system that providers of high-risk AI systems must establish, implement, document, and maintain covering: the regulatory compliance strategy,…
- Post-Market MonitoringProactive collection and review of experience gained from the use of high-risk AI systems, to identify any need for corrective or preventive actions and…
- AI Regulatory SandboxA controlled environment established by a competent authority that offers providers and prospective providers of AI systems the possibility to develop,…
Related compliance controls
- TD-009Change Management ProceduresProviders must document procedures for managing changes to the AI system that could affect its compliance status, triggering re-assessment when a modification is substantial and potentially requiring new conformity assessment.
- RK-010Audit Trail for Conformity AssessmentProviders must maintain a complete audit trail for each conformity assessment, including all documentation reviewed, tests performed, results obtained, and decisions made, to support regulatory scrutiny and re-assessment activities.
- CA-001Conformity Assessment Pathway SelectionArticle 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.
- 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 9–15 and 17, with the internal assessment conducted by qualified personnel independent of the development team.
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Conformity Assessment & CE Readiness
Select the assessment route, prepare Annex VI or Annex VII evidence, coordinate notified-body inputs and track CE-marking readiness.
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