EU Database Registration Summary EU database registration is completed before the system is placed on the market. Annex VIII defines the required information fields: provider identification, system identification, classification basis, conformity assessment route, status, and version details. The registration is maintained and updated when the system status changes (modification, suspension, withdrawal). See for detailed treatment. Key outputs
- Pre-market registration requirement
- Annex VIII information fields
- Ongoing maintenance obligation
CE Marking Summary CE marking is affixed after conformity assessment confirms compliance and the Declaration of Conformity is signed. For AI systems with a physical product, the marking appears on the product. For software-only systems, the marking appears in the documentation, packaging, or accompanying materials. The CE marking signifies that the system conforms to all applicable EU AI Act requirements. Key outputs
- Post-conformity-assessment CE marking
- Physical product vs software-only placement
- Conformity signification
Inspection Readiness Summary Inspection readiness comprises the pre-configured regulatory access IAM role, the 30-minute documentation production drill, designated contact persons for each competent authority, the inspection log tracking all regulatory interactions, and annual readiness exercises. See for detailed treatment. Key outputs
- Pre-configured regulatory access role
- 30-minute documentation drill
- Annual readiness exercises
Multi-Jurisdiction Checklist Summary Multi-jurisdiction deployment requires: identifying the lead market surveillance authority per member state, mapping per-jurisdiction FRIA notification requirements, preparing translations of the Declaration of Conformity and affected person notifications, establishing per-jurisdiction Legal and Regulatory Advisor contacts, and maintaining a jurisdiction register documenting deployment status per member state. See for detailed treatment. Key outputs
- Per-jurisdiction authority identification
- Translation requirements
- Jurisdiction register