New EU Revised Manufacturer Incident Reporting Form

The EU has published Version 7.3.1 of the Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR). The updated MIR form is password protected, therefore it may need to be unlocked for specific purposes, such as translation.

You can request the password for specific authorized uses.

• New manufacturer EU Incident Report XSD files and XSL files (for implementation in manufacturer’s databases)
• New manufacturer incident report helptext
• Changelog file

The newest version EU Incident Report (7.3.1) of the form contains the following changes, compared to the previous form (version 7.2.1) published in 2019.

• Section 1.2: Addition of manufacturer awareness date of reportability. Note this date specifies when the manufacturer received the information that determined that the incident is reportable and thus met the criteria of an incident. This is different from the awareness date, which is when the first employee or representative of the manufacturer’s organization receives information (e.g., a complaint) regarding the incident.
• Section 2.1:
  • Addition of selection ability for UDI issuing agencies.
  • Addition of Master UDI-DI.
• Section 2.4:
  • Ability to select (a) “applicable legislation unknown”.
  • Addition of section (f) related to scientific opinions and companion diagnostics.
  • Section 3.2: Annex A has been linked within the form.
• Section 3.3:
  • Annex E and Annex F have been linked within the form.
  • Annex E and Annex F codes are now required to validate the form (note only choice 1 is required for validation).
  • Section (f) added to list any prior health condition or medication that may be relevant to the incident.
• Section 4.1
  • Addition of section to denote “Suspicion of a relationship between the incident and the medicinal substance(s) / product(s), tissue(s), cell(s) of human origin or their derivative(s) associated with the device?”. Note this field is only applicable for devices referred to in section 2.4f.
  • Annexes B, C, D and G have been linked within the form.
• Section 4.3: Updated to include links for Annex A and Annex C codes.
• Section 4.3.2: Cutoff date for use of inhouse codes defined in help text: “Please be aware that the inhouse codes can only be used until June 2025.”

Mandatory use of the newest version will begin November 2025.

To learn more about the newly revised EU Incident Report click here.

For further information, contact us.

____________________________________________

Learn How MedEnvoy Can Assist you:

• EU Authorized Representative
• EU Regulatory Importer