CA-008HighProviderPreventive
Technical File Preparation for Assessment
Providers must prepare a complete technical file comprising all technical documentation required under Article 11 and Annex IV, organised to support efficient review by market surveillance authorities or notified bodies.
Articles:Article 11(1)Article 43(1)Annex IV
Evidence Examples
- Technical file completeness checklist
- Annex IV structure compliance
- Technical file version control record
Standards
Annex IV EU AI Act
Related controls
- 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…
Related EU AI Act 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 through internal control (Annex VI) or with involvement of a notified body (Annex VII).
- Technical DocumentationThe documentation that providers of high-risk AI systems must draw up before placing the system on the market, containing all necessary information to assess compliance with the Regulation, including a general description, design specifications, training data information, risk management records, and performance metrics. Content requirements are set out in Annex IV.
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