The technical documentation shall contain at least the following information:
1. General description of the AI system:
(a) intended purpose, provider name, version
(b) interaction with other hardware/software
(c) software/firmware versions and update requirements
(d) distribution forms (embedded, downloads, APIs)
(e) hardware requirements
(f) product photographs/illustrations if applicable
(g) user-interface description
(h) instructions for use
2. Detailed description of development process:
(a) development methods and steps
(b) design specifications, logic, algorithms
(c) system architecture
(d) data requirements and datasheets
(e) human oversight assessment
(f) predetermined changes description
(g) validation and testing procedures
(h) cybersecurity measures
3. Monitoring, functioning and control information:
- capabilities and limitations
- accuracy degrees for specific groups
- foreseeable unintended outcomes
- human oversight measures
- input data specifications
4. Performance metrics appropriateness
5. Risk management system description (per Article 9)
6. Lifecycle changes description
7. List of harmonised standards applied
8. EU declaration of conformity copy
9. Post-market monitoring system description