MIR Form v7.3.1: what manufacturers need to anticipate before November 2025
Medical devices regulation
1. Why PMSV remains an underestimated issue
The post-marketing surveillance and vigilance system (PMSV) is at the heart of Regulation (EU) 2017/745 on medical devices. And yet, all too often, it is relegated to the status of an administrative constraint, triggered only "in case of a glitch".
Yet the MIR (Manufacturer Incident Report) form is a central tool for :
- document serious incidents (article 87 of the MDR),
- alert the relevant authorities
- and improve patient safety.
With the arrival of version 7.3.1, mandatory from November 2025, the European Union is reinforcing the harmonization and quality of the data collected. Manufacturers need to start preparing now.
2. What is the MIR v7.3.1 form?
The MIR is the official form for reporting a serious incident involving a medical or in vitro diagnostic device. It applies to :
- incidents occurring in the EU (and associated countries),
- on CE-marked devices under MDR or MDD/AIMDD (legacy devices).
Version 7.3.1, published in July 2025, replaces previous versions (7.2 and earlier) and becomes mandatory for all submissions from November 1, 2025.
The form is available in two formats:
- Dynamic PDF for completion and signature via Adobe Acrobat Pro,
- StructuredXML for integration into EUDAMED.
3. What's new in version 7.3.1?
This version is not just a cosmetic update. It reflects a clear commitment to standardizing report content and structure, with a view to direct integration into EUDAMED.
Main changes :
- Mandatory IMDRF fields (problems, clinical effects, investigation, components, etc.)
- Addition of EMDN coding for all devices
- Explicit distinction between legacy, MDR and "old" devices
- Cross-referencing possible with FSCA or PSR
- Future pre-filling by EUDAMED (SRN, UDI, etc.)
- New section 4.3 for statistical data on similar incidents
Changes with MIR v7.3.1 (July 2025)
|
Element |
Type of change |
Detail / comment |
|
IMDRF fields (Appendices A to G) |
Made mandatory |
Systematic coding of problems, clinical effects, investigations, components |
|
EMDN coding |
Added |
Mandatory identification of DM via EMDN, linked to EUDAMED |
|
Reference to a PSR or FSCA |
Added |
Optional fields, but recommended if an action is already in progress |
|
Distinction legacy / MDR / old devices |
Addition clarified |
Specific filling rules according to DM status are now spelled out |
|
Manufacturer and AR SRN referencing |
Reinforced |
Still expected, even if "Unknown" is still accepted before full EUDAMED |
|
UDI-PI |
Now mandatory for MDR/IVDR DMs |
Required for all non-legacy devices (if unknown: "Unknown" initially) |
|
Information on accessories / systems |
Better structured |
Need to declare each DM involved separately via a dedicated MIR |
|
Section 4.3 - Similar incidents |
Added |
Quantitative data to be provided by period to contextualize incident frequency |
|
Future auto-completion via EUDAMED |
Planned |
Some fields will be automatically filled via SRN or UDI (to be anticipated) |
|
Automated control of mandatory fields |
Reinforced |
PDF signature blocked if certain mandatory fields are missing |
4. How to fill in the MIR correctly? Two practical cases
Case 1: Incident involving a device still under MDD certification
Let's imagine an MDD-certified hip implant (class IIb), placed on the market in 2020. In 2025, a serious incident occurs in France.
In this case :
- Mention the applicable legislation: MDD
- Indicate SRN, if available (otherwise "Unknown")
- Provide a full clinical description
- Complete IMDRF sections (codes A, E, C...) even if the device is legacy
⚠️ The form does not allow new fields to be "dispensed with" on the grounds that the DM is legacy.
Case 2: Incident during a PMCF study
A manufacturer is conducting a post-market study (PMCF) on an implantable MDR device. One of the patients presents an unexpected complication.
To do:
- Indicate the EUDAMED number of the PMCF study (if available)
- Fill in the "Manufacturer awareness date" and "reportability date" fields
- Report the incident using IMDRF codes Annex A and E
- Assess whether corrective or preventive action (CAPA) is required
Even if the study is still in progress, the reporting deadline remains 15 days from knowledge of the incident.
Checklist: Preparing to submit an MIR
- 1.Identify applicable legislation (MDD, MDR...)
- 2.Gather administrative data (SRN, UDI, manufacturer, AR...)
- 3.Describe the incident in plain language (clinical signs, effects...)
- 4.Use relevant IMDRF codes (Appendices A to G)
- 5.Check deadlines: submission within 10 or 15 days
- 6.Document measures taken (CAPA, FSCA...)
- 7.Compile similar incidents (section 4.3)
- 8.Submit in signed PDF or XML format via EUDAMED/email
5. What manufacturers need to anticipate now
To avoid bottlenecks (or worse, uncontrolled recalls), here are the actions you need to take:
- Update your internal vigilance procedures (SOPs)
- Train the people in charge: RA, PRRC, distributors
- Check SRN availability (manufacturer + RA)
- Provide UDI, EMDN and IMDRF data
- Prepare your systems to generate structured XML
CSDmed can support these upgrade steps.
6. Mini FAQ
Can I still use the previous version after November 2025?
No. As of November 2025, only version 7.3.1 will be accepted for all MIR declarations.
Do I need one form per device if several are involved?
Yes, 1 MIR = 1 device. Accessories must be listed, but each DM involved requires its own MIR.
What should I do if certain data are not available?
Indicate "Unknown" in the relevant fields. It is possible to complete the data via a subsequent Follow-Up.
Do older devices need a UDI?
No, but alternative identifiers will be required. The form help gives the rules for "old devices".
Can the vigilance function be delegated?
Yes, to a service provider or an RA. The tenderer's name and contact details must appear in the MIR.
7. CSDmed, your ally for controlled vigilance
The new MIR is more than just a form. It reflects your regulatory maturity in terms of PMSV. And at a time when EUDAMED is being rolled out, failure to anticipate means exposing yourself to delays, blockages and even sanctions.
At CSDmed, we support manufacturers :
- updating their PMSV procedures,
- preparing MIR declarations,
- and training their teams in these new tools.
Need a diagnosis of your vigilance practices, or one-off support for a sensitive declaration? Let's talk.