EU AI Act glossary · Documents & conformity· Art. 43
Conformity assessment
A conformity assessment (Article 43) is the process by which a provider demonstrates a high-risk AI system meets the Act's requirements before it is placed on the market — either via internal control (Annex VI) or a notified body (Annex VII).
Most Annex III systems use internal self-assessment; a notified body is required in specific cases (e.g. certain biometric systems without harmonised standards). A substantial modification triggers a new assessment.
Conformity assessment explained
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