Support for EC Manufacturer Incident Report (MIR) version 7.3.1

Summary

Support for EC Manufacturer Incident Report (MIR) version 7.3.1 (Enhancements 38335935 and 38509479)

Description

Argus Safety is enhanced to support the Manufacturer Incident Report (MIR) version 7.3.1 (SB-10781) published by the European commission in December 2025.

Note:

The European Commission released MIR version 7.3.1 (SB-11010) in March 2026. We will support this update in a future release. SB-11010 includes only technical corrections to the PDF and does not introduce any new regulatory content or data fields.

The enhancements include new Interchange profiles, new fields to support new elements, code list have been updated with new values and attributes, length changes to existing case form fields.

Code list updates
The following flexible code lists are enhanced:
  • New factory data value is added for Medical Device Info
  • New factory data and attributes are added for Device UDI System and Risk Class Type
  • New attribute is added for Manufacturer
Configuration related updates
The following are new fields included in License configuration screen:
  • Issuing Entity Basic UDI-DI
  • Device Description
  • Agency Delivering Scientific Opinion
  • Name(s) of Medicinal Product associated with the device
Interchange mapping

A new profile, EC-MIR V7.3.1 MESSAGE TEMPLATE, is provided with default export mappings. There are no updates made to the existing MIR 7.2.1 profile, as the users with reporting obligation to European Commission are expected to use the MIR 7.3.1 profile.

For mapping changes, see the ArgusInterchange_2026.1.01_MIR7.3.1_Export Mappings sheet.

Report generation, tracking and transmission

MIR reports can be scheduled or generated manually or automatically. The MIR viewer allows you to preview the report and to switch between XML and PDF formats.

When the final MIR report is generated, it can be transmitted manually or automatically via Argus services. MIR reports are transmitted to the configured agency by email only, and the report is sent in XML or PDF format based on the reporting destination configuration. You can track transmission of MIR reports in the Bulk Reporting screen, and you can view submitted reports under Worklist > Bulk Transmit.

Regenerating an MIR 7.3.1 report for a previously generated MIR 7.2.1 report with the status set as New data available is not supported. It is recommended to create a follow-up MIR instead of regenerating the report.

Validation

During MIR report generation, the application generates a validation report with the details of validation errors. MIR validations are not carried out against the native Argus Interchange validation framework. Instead, case data are validated against the XSDs provided by the European Commission.

Case Form enhancements
New fields have been added in Products > Device window to capture additional device related data to support MIR reporting:
  • Issuing Entity UDI-DI
  • Issuing Entity Unit of Use UDI-DI
When coding is performed using IMDRF annexures, if there is no appropriate IMDRF code available to describe information required in the relevant Annexures, the European Commission (EC) recommends the use of specified default IMDRF codes along with a brief explanation of why a suitable code or term could not be selected. In Prior version of Argus, you were allowed to select either a IMDRF code or enter free text in the IMDRF lookup corresponding to various annexures. If you selected the IMDRF code along with free text, then the IMDRF code was cleared and only the free text was retained. Now, if you select an IMDRF code and enter free text, then the IMDRF code and the free text data are retained in the relevant fields available in the sections listed below.
  • Annex A—Products > Device > Device Problem Information
  • Annex B , Annex C, Annex D—Products > Device > Evaluation /Investigation Code Information
  • Annex E—Events > Clinical Signs IMDRF Code
  • Annex F—Products > Device > Health Impact Information
  • Annex G—Products > Device > Device Component Information

In the Products > Device > EU/CA Device window, the Does the incident represent a serious public health threat? field is renamed to Does the incident qualify to be reported?. When you set this field to Yes, then the new field introduced Manufacturer awareness date of reportability is automatically populated with the current system date, which can be changed to the user's preferred date.

The following enhancements have been made to the Products > Device > Similar Incidents window:
  • Similar Incident Analysis Based on field is added, with a new dropdown option Annex C.
  • New EEA+TR+XI fields have been introduced to capture results of counts of similar incidents and devices.

Note:

The existing EEA+CH+TR fields are retained only for displaying legacy case data and in MIR 7.2.1 profile mappings but are not used in MIR 7.3.1 XML export mapping.

The identification and computation of count of similar incidents and devices is performed outside the Oracle Argus system, and fields are provided to capture the results in the Similar Incidents window.

Argus Safety Japan enhancements for JFMDA

As a Japanese user, if you select any term from the standard JFMDA dictionary that is associated with a different IMDRF code than the one entered by the global user, then an error message is displayed indicating that the IMDRF free text cannot be overwritten.

When there are data already available containing IMDRF code and term in a globally locked and locally unlocked case, a Japanese user is now able to successfully add the JFMDA code associated with the same IMDRF code.

Field length enhancements
Data length for the following fields has been increased as per guidelines from European Commission:
  • EU/CA Device tab
    • Remedial Action by HC Facility is changed from 1000 AN to 2000 AN
    • Rationale for Not Reportable is changed from 2000 AN to 4000 AN
    • Rationale is changed from 2000 AN to 4000 AN
  • Products > Device tab
    • Preliminary Comments is changed from 2000 AN to 4000 AN
    • QC Result is changed from 2000 AN to 4000 AN
For changes to the Case Form fields and Argus Console fields, see the OracleArgusSafety2026.1.01_CaseForm_Console_Updates_Summary document.
For more information on MIR report configuration and FAQ details, see the Manufacturer Incident Report (MIR) Best Practices.

Note:

With the introduction of the Textfields Printable Summary section in the MIR 7.3.1 (SB-10781) PDF report template, the previous PDF Grow field data output on the continuation page has been removed.

For the list of text fields printed in this new section, refer to the ArgusInterchange_2026.1.01_MIR7.3.1_Export Mappings sheet.

Parent topic: Regulatory enhancements