MIR Process Overview

Manufacturer Incident Reports (MIRs) contain information about adverse events, serious injuries, deaths, or malfunctions related to medical devices.

The following flowchart shows the steps to follow when working with MIR reports.

The following table describes each step process.

Task	Description
Log in	Log in to Oracle Argus Safety.
Device Data Entry	Enter device information.
Schedule MIR Report	Schedule an MIR report for a case manually or using auto-schedule.
View and Validate MIR Report	View a scheduled MIR report in the MIR Viewer and check for validation errors.
Transmit MIR Report	Transmit the MIR report by using the Bulk Reporting screen in Oracle Argus Safety.
View Report Status	View the status of a transmitted MIR report.

For more information, refer to the EC Manufacturer Incident Report (MIR) Best Practices document.