CA-007HoogAanbiederPreventief
Triggers voor herbeoordeling van conformiteit
Artikel 43, lid 4, vereist dat aanbieders de conformiteit opnieuw beoordelen wanneer een substantiële wijziging aan het AI-systeem wordt aangebracht, inclusief wijzigingen die het beoogde doel, de prestatiekenmerken of de classificatie onder bijlage III beïnvloeden.
Artikelen:Article 43(4)Article 6(3)
Bewijs voorbeelden
- Substantial modification criteria document
- Change classification procedure
- Re-assessment trigger log
Normen
Article 43(4) EU AI Act
Gerelateerde controles
- 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…
- 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…
Gerelateerde AI-verordening-begrippen
- Risk-Based ApproachThe overarching regulatory framework of the EU AI Act that categorises AI systems by the level of risk they pose — prohibited, high-risk, limited-risk, and minimal-risk — and imposes proportionate obligations accordingly.
- High-Risk AI SystemAn AI system that poses significant risks to health, safety, or fundamental rights, as listed in Annex III (e.g. biometric systems, critical infrastructure management, educational assessment, employment tools, essential services, law enforcement, migration and border control, administration of justice) or embedded as a safety component in products covered by Annex I.
- Conformity AssessmentThe 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).
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