2 Minimum Requirement for MIR Report Generation

• General Tab
  • 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
  • One adverse event/reaction (or outcome) which has causality marked as related.
• Product Tab
  • 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.
  • At least one Evaluation/Investigation code information and Device Component information for Combined Initial & Final and Final Report types.
  • Preliminary Comments are updated for Device Product.
  • EU CA Dialog information is updated (Manufacturer Awareness Date of Reportability, Location of Device, MIR Report Type, Root Cause Information, Investigation Result, 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 document.