Medical device companies in Europe and pharmaceutical companies share a unique business challenge, inability to…
The MDR race has started, Are you surprised?
The new form Manufacturer Investigation form for reportable events in EU is mandatory starting this November 2025.
MDR Compliance (Article 120) / New Manufacturer’s Investigation Form
Non-serious events demonstrating a trend or significant risk management changes that occur during post market surveillance also must be reported.
>The new form requires EUDAMED information and product UDI-DI and basic UDI-DI.
What Changed?
Comparing the previous form to the new form, the following significant changes impact complaint investigation and reporting:
| Field | Change / Difference from Previous MIR form |
| 1.2d | Manufacturer Awareness Date of reportability is now required |
| 1.3.1f | Identification if the incident occurred as part of the Post market clinical follow-up (PMCF) |
| 2.1a | ‘Issuing entity’ of UDI-DI and ‘Unit of use’ (e.g. GS1) |
| 2.1c | Basic UDI-DI (New MDR requirement that requires registration in EUDAMED) |
| 2.4f | Determination if product falls one of the following:
1. device is incorporating a medicinal substance, OR 2. manufactured utilizing, or incorporating, tissues or cells of human or animal origin, or their derivatives, that are non-viable or rendered non-viable, OR 3. devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body |
| 4.1b | If 2.4f is applicable, ‘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?’ must be determined as part of the root cause investigation. |
| Various | Mandatory use of IMDRF codes and terms from Annex E,F, and G |
Note: There are some new optional fields (e.g. height of patient) that have also been added but is not required for initial or final submission of the form.
What does this impact?
After November 2025, applicable complaints will likely be evaluated during audits to determine whether the new form was used or if the procedure was updated.
If you haven’t registered in EUDAMED, the following starter kit of procedures will show you the necessary steps to register.
>EU Manufacturer: Initial Steps for Remediation – Product Detail – QMS Velocity
>Non EU Manufacturer: Initial Steps for Remediation – Product Detail – QMS Velocity
For an updated Vigilance Procedure including the requirements needed to align with the MIR 7.3.1, please use the following links:
>EU Manufacturer: Vigilance Procedure – EU_Mfg-MDR
>Non-EU Manufacturer: Vigilance Procedure – Non_EU_Mfg-MDR
If a root cause procedure is need, use the following link: Root Cause Analysis Procedure-MDR
For a complaint procedure incorporating identification of reportable non-serious events that must be reported, use the following link:
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