Annex IV: Technical documentation
The structured content of the technical file. Commonly summarised as ~8-9 blocks: (1) general system description; (2) detailed description incl. development process; (3) monitoring/functioning/control; (4) risk-management; (5) lifecycle changes; (6) standards applied; (7) EU declaration of conformity; (8) post-market monitoring plan; plus data-governance substantiation (Art. 10 records).
Sections
- anx-4-1 — General description of the AI system
- anx-4-2 — Detailed description incl. development process & data
- anx-4-3 — Monitoring, functioning and control
- anx-4-4 — Risk-management system
- anx-4-5 — Lifecycle changes
- anx-4-6 — Harmonised standards applied
- anx-4-7 — EU declaration of conformity
- anx-4-8 — Post-market monitoring plan
Related obligations
Legal source
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