Annex IV technical file
The full technical documentation package; primary evidence at conformity assessment; must be a living, versioned document.
- Artifact type
- dossier
- Record basis
- Contemporaneous — create it when the decision is made
- Annex IV section
- anx-4
- Primary source
- Art. 11 AIA · Annex IV AIA
Which obligations this evidences
- Declare accuracy metrics in instructions for use
- Evidence robustness / resilience
- Evidence AI-specific cybersecurity
- Run a lifecycle risk-management system
- Govern training, validation and test data
- Draw up & maintain the Annex IV technical file
- Complete conformity assessment before market
Red flags on this evidence
Fails an audit
- Documentation created after the fact rather than contemporaneously with the decision — national competent authorities apply the contemporaneous standard.
- No clear version control / traceability between document versions and system versions.
Legal source
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