2 Minimum Requirement for MIR Report Generation
- General Tab Updates
- One identifiable reporter – A reporter can be a Patient, Lay User or HCP. It is recommended that at minimum the Role of the Reporter and the Country of the reporter are updated.
- Event Tab Updates
- One adverse event/reaction (or outcome) which has causality marked as related and at least one seriousness criteria selected.
- Product Tab Updates
- One Suspect Device Product (License Information is updated: Risk Class, Notified Body Details)
- One Health Impact Information is updated
- One Medical Device Problem Information is updated
- Preliminary Comments are updated for Device Product
- EU CA Dialog information is updated (Location of Device, MIR Report Type, Root Cause Information, Corrective Action and Projected Timing Information and Comments)
- Similar Incidents Tab is updated for Final Reports
Note:
For more information on validation rules, refer to the Conformance Tab ofMIR_Export_Mappings.xlsx
.