European Commission Releases New Management Incident Report Form and Help Text

By Amelia Boldrick and Elizabeth Pugh

MIR version 7.3.1 is released

The European Commission (EC) has at last released (May 5) the long-awaited version 7.3.1 of the Manufacturer Incident Report (MIR) form to report serious incidents. Additionally, the EC has also published a new help text file with information on completing the new report form, as well as the corresponding XSD and XML schema files to facilitate the integration of complaint management software with the new form.

Version 7.3.1 is mandatory for November 2025

Use of the new form is optional until November 2025, when manufacturers are expected to have fully transitioned (from version 7.2.1).

What’s new in version 7.3.1:

•  International Medical Device Regulators Forum (IMDRF) Annex E and F codes are compulsory (while technically expected previously, the form did not require them). Additionally, IMDRF Annex G code is required for a final report. Importantly, when specific components do not apply to a subject device, manufacturers will need to select G07001- Part/Component/Sub-assembly Term not Applicable, rather than leaving the field blank.
• The form features separate fields for the date of manufacturer awareness and awareness of reportability as described in question 15 of MDCG 2023-3.
• Section 2 includes fields for the identification of the UDI-issuing entity.
• Device description and nomenclature text are separate fields instead of a choice.
• It is possible to indicate ‘unknown’ when selecting the applicable legislation under which the subject device was placed on the market, and to indicate when a legacy device has continued to be placed on the market after the date of application of the new regulations.
• Additional fields have been added in alignment with the EMA’s expanded mandate with regard to EU expert panels.
• Great Britain and Switzerland have been removed from the European Economic Area (EEA) countries identified in the market distribution section, while Northern Ireland (XI) has been added.
• In addition to totals for the country of incident and worldwide, manufacturers will calculate similar events for the EEA + Turkey + Northern Ireland, rather than the EEA + Turkey + Switzerland.
• The XML file can be saved directly from the report form or sent via email, whereas version 7.2.1 of the form only allowed for the latter.

New form, new help text

The version 7.3.1 help text is now downloadable as a PDF file, and like its predecessor is intended to clarify the information needed in each of the report form fields and to identify which are mandatory according to the type of report to be submitted: initial, follow-up, final, and combined.

However, unlike its predecessor, the new version of the help text includes supplementary resources and links to assist with the selection of European Medical Device Nomenclature and IMDRF adverse event (AE) terminology and codes.

Concluding remarks

Although the EC has not yet released updated Field Safety Corrective Action or Trend report forms, the release of the updated MIR form is an important milestone in the broader effort towards vigilance reporting in EUDAMED. We have been informed that this form is not currently compatible with EUDAMED so another version will be expected prior to mandatory EUDAMED use.

The requirement to include the IMDRF AE codes further advances the development of systems to improve global market surveillance and PMS.