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.

The following are the updates to support the new MIR 7.2.1:

• 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.

Based on the updates to CFG_FDA_IMDRF_CODES, the allowed values for the following profiles has been updated with the new values:

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

The Incident information and Manufacturer Final Investigation results sections in the 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.