EC Manufacturer Incident Report (MIR) updates
The European Commission has released updated version of Manufacturer Incident Report (MIR) 7.2.1 that allows data to be transmitted in PDF format and XML format to National Competent Authorities and Notified Bodies.
- Mapping updates to the existing tags.
- Support for new XSD MIR 7.2.1 provided by the European Commission.
- New MIR 7.2.1 PDF report.
Regulation updates
Based on the new IMDRF Annexures released in August 2020 by IMDRF/FDA, the CFG_FDA_IMDRF repository has been updated to support storage of the new annexures for Device Problem, Evaluation Codes, Clinical Signs, and Health Impact.
Profile Impacted | Element Name [Number] |
---|---|
ICH-ICSR V2.2 MESSAGE TEMPLATE - FDA | EVALUATIONVALUE [B.4.k.20.FDA.19.1b] |
CBER EVAERS V1.0 MESSAGE TEMPLATE | DEVICEPROBLEMCODE [FDA.G.k.12.r.3.r] |
Case form changes
Product > Device
tab have been deprecated.
- Device Evaluation Type Level
- Device Event Type Level
Interchange mapping utility changes
The mapping logic of the following elements have been revised for the existing MIR Message Template EC-MIR MESSAGE TEMPLATE:
- imdrfClinicalCodeChoice1 to 6
- adverseEventDateFrom
- deviceClass
- otherCountries
- otherCountriesLi
- distribution_all
Validation check
Based on the MIR 7.2.1 XSDs released by the EC, XSD Version 7.2.1 of 05.2020 has been adapted as part of this release to support validation of the MIR Reports.
For more information, refer to the ArgusInterchange823_MIR Export Mappings.xlsx.
Parent topic: Enhancements to Oracle Argus Safety