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.
• 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 of MIR_Export_Mappings.xlsx.