Enable European Union Manufacturer Incident Report (EU MIR) PDF Generation

Learn how to configure EU MIR form generation from a Case.

About the Feature

With the 25R2 release, Veeva Safety supports the generation and submission of the European Commission’s Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD), Version 7.2.1, formatted as a PDF with the European Union (EU) template. This feature introduces objects, fields, and actions that enable populating the core data elements required for compliant generation and transmission to the European Database on Medical Devices (EUDAMED).

After configuring this feature, see EU MIR Generation Data Mapping and Case Field Reference for more information.

Overview

Complete the following procedures to configure EU MIR Form Generation in your Vault:

Update the Case Product Layout

To update the Device Detail Page Layout of the Case Product object layout:

  1. Add the following fields to the Device Information section:
    • Current Device Location
    • Current Device Location (Other)
    • Device Nomenclature Code
    • Implant Facility
    • Explant Facility
    • Relevant Accessories
    • Relevant Associated Devices
    • Software Version
    • Firmware Version
    • UDI Production Identifier
    • Unit of Use UDI-DI
    • Unique Identifier
    • Usage of Device (Other)
  2. Add a Detail Form section:
    • Section Label: Enter Device Incident Report
    • Section Layout: Select Detail Form - Two Columns
  3. As needed, based on your business process, add the following fields to the new Device Incident Report section:
    • Devices Marketed Criteria
    • Devices Marketed Criteria (Other)
    • EUDAMED FSCA Reference Number
    • EUDAMED Reference Number
    • Expected Date of Next Report
    • IMDRF Similar Incident Identification
    • IMDRF Similar Incident (Other)
    • Manufacturer FSCA Reference Number
    • Manufacturer Reference Number
    • Medical Device Terminology
    • Medical Device Terminology (Other)
    • NCA FSCA Reference Number
    • NCA Reference Number
    • Not Reportable Rationale
    • Similar Incident Basis
    • Similar Incident Basis Details
    • Similar Incident Comments
    • Submitter of Report
    • Submitter of Report (Other)
    • Type of Incident Report
  4. Add a Detail Form section:
    • Section Label: Enter Manufacturer Analysis
    • Section Layout: Select Detail Form - Two Columns
  5. As needed, based on your business process, add the following fields to the new Manufacturer Analysis section:
    • Corrective/Preventative Action
    • Corrective/Preventative Action Schedule
    • Further Investigations
    • Impact and Risk Analysis
    • Initial (Corrective/Preventative) Actions
    • Investigation Summary and Conclusion
    • Is root cause confirmed?
    • Preliminary Results and Conclusions
    • Risk assessment reviewed?
    • Root Cause Description and Conclusion
  6. Add the Case Product Similar Incident related object section.

Update the Case Contact Layout

Add the PO Box field to applicable layouts of the Case Contact object.

Update the Case Product Device Code Layout

Add the Rank field to the Case Product Device Code Detail Page Layout of the Case Product Device Code object.

Update the Product Layout

To update the Device Detail Page Layout of the Product object layout, add the following fields to the Details section:

  • Basic UDI-DI
  • Brand Name
  • Description of Device

Update the Product Registration Layout

To update the Product Registration Detail Page Layout of the Product Registration object layout, add the following fields:

  • MDD/AIMDD Risk Class
  • IVDD Risk Class
  • MDR Class
  • MDR Type
  • IVDR Class
  • IVDR Type
  • Notified Body ID
  • Notified Body Certificate Number
  • Device Market Date Type
  • Device Market Date

Update the Organization Layout

To update the Organization object layout:

  • On the Agency Detail Page Layout, add the EUDAMED Number field.
  • On all layouts other than the Agency Detail Page Layout and the Ethics Committee Detail Page Layout, add the Single Registration Number (SRN) field.

Update the Transmission Layout

Add the Case Product field to the Submission Detail Page Layout and Distribution Detail Page Layout layouts of the Transmission object.

Configure the Generate Similar Incident Records Action on Case Products

To configure the Generate Similar Incident Records action, assign the action to the Case Product object and do any of the following, according to your business process:

  • Add the action as a user action to the applicable states of the Case Product Lifecycle object lifecycle.
  • Add the action as an entry action on any Case Product Lifecycle object lifecycle state.