- E1. Declaration of Conformity
- E2. EU Database Registration Entry
- E3. CE Marking
- E4. Instructions for Use (IFU)
- E5. AISDP (Twelve-Module Documentation Package)
- E6. Serious Incident Reports
- E7. FRIA Report
- E8. Data Protection Impact Assessment (DPIA)
- E9. Affected Person Notification Templates
- E10. Regulator Contact Register
- E11. Break-Glass Procedure Documentation