Compliance & AssessmentArticle 3(27)Article 40
Harmonised Standard
A European standard developed by a recognised European standardisation organisation (CEN, CENELEC, or ETSI) upon request from the European Commission, compliance with which creates a presumption of conformity with the corresponding requirements of the Regulation.
Related terms
- 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…
- 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…
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