The Manufacturer Incident Report (MIR) is the form used by medical device manufacturers. They report serious incidents in Europe using it. This is done under the MDR and IVDR rules.
In 2025, a new version called MIR 7.3.1 was released. While the intention was good, the first releases had some technical problems. These issues caused confusion and extra work for manufacturers.
In December 2025, an updated and corrected version of MIR 7.3.1 was released. This version is now considered stable and will become mandatory from 1 May 2026.
This blog explains what MIR 7.3.1 is. It details what problems existed in earlier versions. It also covers what was fixed in the December 2025 update. Finally, it outlines what manufacturers need to do next.
What Is MIR 7.3.1
MIR 7.3.1 is the standard form used to report serious incidents. It is also used for follow up reports and final reports for medical devices covered by MDR and IVDR.
MIR 7.3.1 does not change reporting timelines, legal reporting obligations, or the definition of a serious incident. The goal of this version is to make reporting clearer and more consistent, especially when using PDF and XML submissions.
Problems in Earlier MIR 7.3.1 Versions
When MIR 7.3.1 was first introduced in 2025, many manufacturers experienced technical issues.
Some common problems were data entered in Section 2.5 Data for the market distribution was not being saved correctly. Users were unable to select only Annex A IMDRF codes in Section 4.3.1a, mandatory fields not always being clearly marked, and differences between PDF behavior and XML validation rules.
Because of these issues, many manufacturers were unsure whether they should use MIR 7.3.1 or continue with MIR 7.2.1. Industry feedback also indicated that implementation of MIR 7.3.1 would likely be delayed until a corrected version was available.
What Changed in the December 2025 Update
The December 2025 update of MIR 7.3.1 focused on fixing technical and usability issues. No new reporting rules were introduced.
Easier to Use MIR PDF
Free text fields now have a fixed size and all entered text is automatically copied to the end of the PDF for easier review and printing. Mandatory fields are now clearly marked. Submission buttons have been simplified and electronic signature is no longer mandatory.
This makes the form easier to complete, review, and archive.
Clearer IMDRF Coding
IMDRF coding rules are now applied correctly. Incorrect mandatory use of Annex C in some report types has been removed. The PDF, Helptext, and XML rules are now aligned. This reduces rework and follow up questions from authorities.
XML and XSD Technical Fixes
XML export issues have been fixed and XML import into the PDF is more stable. Old and unused XML fields were removed and mandatory rules in XSD files were corrected. This improves the reliability of automated reporting systems.
Better Help and Guidance
The Helptext now includes a clear list of all free text fields that appear at the end of the PDF and simple instructions on how to split the MIR PDF using Adobe Acrobat. This helps with internal review and audit preparation.
What Did Not Change
There are no new reporting timelines, no new legal duties, and no new data fields. MIR 7.3.1 is a technical improvement and not a regulatory change.
When Does MIR 7.3.1 Become Mandatory
The updated MIR PDF was released on 22 December 2025. Mandatory use of MIR 7.3.1 starts from 1 May 2026.
From this date, all new MIR submissions should use MIR 7.3.1. Older versions may be rejected. Manufacturers should ensure their systems and procedures are updated in time.
What Manufacturers Should Do Now
Manufacturers should update MIR templates and tools, align XML validation files, train vigilance teams on the updated form, and check with software vendors if XML reporting is used. Preparing early will help avoid delays and rejected reports.
Final Message
MIR 7.3.1 is now ready for use. The December 2025 update fixed earlier problems and created a stable form ahead of mandatory use in 2026. Manufacturers who prepare now will have a smoother transition and fewer reporting issues later.
Below is a concise, one-page change summary strictly based on the December 2025 MIR 7.3.1
Change Summary (PDF vs XML/XSD)
A. Changes Affecting MIR PDF ONLY
1. Free-Text Field Handling (All Sections with Narrative Fields)
PDF change
- All free-text fields are now fixed size
- Content entered is automatically duplicated in a printable “extra fields” section at the end of the PDF
Affected sections (examples)
- Section 3.1.a – Description of the incident
- Section 4.1.a – Manufacturer preliminary analysis
- Section 4.2.a – Root cause analysis
- Section 4.2.g – Corrective / preventive actions
- Section 5 – General comments
Impact
- Improved readability and printing
- No risk of hidden or truncated text
2. Mandatory Field Visual Indicators Fixed
PDF change
- Red mandatory borders now display correctly where fields are mandatory
Affected fields
- Section 1.1.a – Name of receiving competent authority (ncaName)
- Section 1.2.f – Expected date of next report (reportNextDate)
- Section 4.2.a – Root cause analysis (rootCauses)
- Section 4.2.e – IMDRF Cause Investigation codes
Impact
- Reduced false “complete” PDFs that fail XML validation
3. Signature and Submission Workflow
PDF change
- Electronic signature set to optional
- Date auto-populated when signing
- Buttons renamed and simplified:
- “Before submitting”
- “Export and / or submission”
Impact
- Faster approvals
- Better alignment with real-world workflows
4. New Helptext Sections Referenced from PDF
PDF / Helptext usability
- Section 6 – List of extra fields displayed at end of PDF
- Section 7 – Guidance for splitting MIR PDF using Adobe Acrobat
Impact
- Easier internal review and document handling
B. Changes Affecting XML / XSD / XSL ONLY
5. XML Export and Security Fixes
Technical change
- Updated PDF security settings to fix XML export issues
Affected artefacts
- All MIR XML exports from PDF
Impact
- XML export no longer blocked or corrupted
6. Removal of Obsolete XML Elements (Notified Body Certificates)
XSD / XSL change
Removed elements:
nbCertNumLInbCertNum2LI
Affected schemas
- incident-InitialFinal-v7.3.1.xsd
- incident-FinalRep-v7.3.1.xsd
- incident-FinalNonRep-v7.3.1.xsd
Impact
- Cleaner XML
- Fewer schema validation errors
- No change to reporting obligations
7. Mandatory Flag Corrections in XSD
XSD change
- Corrected
minOccursfor multiple elements following stakeholder feedback
Examples
- Section 1.3.3 – Authorised Representative fields
- Section 4.2.d – Risk assessment review fields
- Section 4.3.1.a – IMDRF Annex C no longer incorrectly mandatory
Impact
- XML validation aligned with intended business rules
C. Changes Affecting BOTH MIR PDF AND XML/XSD
8. IMDRF Coding Logic Alignment
PDF + XSD change
- Correct enforcement of “Choice 1” IMDRF codes
- Annex C Investigation Findings no longer mandatory in incorrect report types
Affected sections
- Section 3.2.a – IMDRF Medical Device Problem (Annex A)
- Section 3.3.a – IMDRF Health Effects (Annex E/F)
- Section 4.2.e – IMDRF Cause Investigation (Annex B/C/D)
Impact
- Fewer rejections
- Clearer coding expectations
9. Risk Class and Market Distribution Stability
PDF + XML change
- Improved import stability for:
- Section 2.4 – Risk class
- Section 2.5 – Market distribution
Impact
- Reliable XML ↔ PDF round-tripping
- Reduced manual correction
10. Country Naming and Enumeration Fixes
PDF + XSD change
- Corrected country labels and enumerations:
- “XI – Northern Ireland”
- Fixed spelling in “All EEA, Turkey and Northern Ireland”
Affected section
- Section 2.5 – Market distribution
Impact
- Consistent data across systems
- Avoids CA clarification requests
