New Manufacturer Incident Report template and IMDRF terminologies for categorized Adverse Event Reporting released
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New Manufacturer Incident Report template and IMDRF terminologies for categorized Adverse Event Reporting released
Regulatory Affairs Medical Devices In Vitro Diagnostics
Wednesday, 14 May 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On May 5th, 2025, the European Commission published a new revision of the Manufacturer Incident Report (MIR) template for reporting of serious incidents under Regulation 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR).
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New Manufacturer Incident Report template and IMDRF terminologies for categorized Adverse Event Reporting released
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This template will become mandatory as from November 2025. Next to the pdf template, also the MIR XSD and XSL files for manufacturer’s database implementation and a guidance document were published
As the MIR requires mandatory use of incident categories and codes established by the International Medical Device Regulators Forum (IMDRF), it is important to note that the IMDRF terminologies for categorized Adverse Event Reporting (IMDRF/AE WG/N43) were also updated on March 3rd, 2025.
What is new/updated in MIR v7.3.1 and IMDRF/AE WG/N43:
Version 7.3.1 of the Manufacturer Incident Report (MIR) template for reporting of serious incidents under MDR/IVDR replaces version 7.2.1. The changes are mostly stylistic and rewording of previous text.
Some content changes include:
- the requirement to specify both the awareness date of the incident and the awareness date of reportability,
- the explicit requirement to specify if there is a suspected or confirmed relationship between the incident and the device
- some changes related to Brexit and the current absence of a functional vigilance module in Eudamed.
Of particular interest is the MIR guidance document, published alongside the new template. It provides line per line more information and help to correctly fill in the MIR template.
Throughout the 7 Annexes of IMDRF/AE WG/N43, 37 new terms were added, 56 terms were modified, and 8 terms were retired.
What does this mean to you?
MIR v7.3.1 will be mandatory as from November 2025 to report serious incidents as part of the EU Medical Devices Vigilance System. It is therefore a crucial form for all manufacturers of (in vitro diagnostic) medical devices with products on the EU market. Since incident coding with IMDRF terms is a mandatory requirement, it is also crucial to use the latest version of IMDRF/AE WG/N43.
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