Support for EC Manufacturer Incident Report (MIR)
The European Commission (EC) has released the Manufacturer Incident Report (MIR) version 7.2 in September 2019. The national competent authorities accept the new MIR PDF and XML report, and manufacturers continue to follow the existing MIR processing workflow. The MIR PDF or XML is required to be submitted by manufacturers to notified bodies.
Oracle Argus Safety has been enhanced to support scheduling, generating, tracking, transmitting, and submitting MIR PDF or XML reports, according to MEDDEV guidance. MIR is implemented as a new report in Oracle Argus Safety, and it supports both PDF and XML formats.
Oracle Argus Safety has been enhanced to enable the MIR report in Oracle Argus Safety: new fields have been introduced, the length of existing fields has been increased, codelist values have been updated, new flexible codelists have been added, and new fields have been added to the Reporting Destination configuration.
For more information, see: