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30 December 2025Background
Manufacturer Incident Report (MIR) Form 7.3.1 was originally published May 2025 and was originally intended to become mandatory in November 2025. However, this date was postponed so that the document could undergo further revisions.
Overview
The updated MIR Form 7.3.1 (SB-10781) was published on 22 December 2025: HERE
When does it become mandatory?
As noted on the webpage, its use becomes mandatory starting Friday, 1 May 2026.
What changed in the MIR form?
On the surface, only minor usability improvements appear to have been made. However, new features have been added to help with easier drafting of the form. The full list of all changes can be found in the change log.
1) Duplicate free form text for easier review and revision
The form will now automatically take the information you type into free form text fields, and duplicate them at the end of the MIR form.
Why? The form’s input boxes are small. Users can only see 4-5 lines at a time, even though fields allow up to 4,000 characters. Therefore, the MIR form will automatically copy long-text content into an “Extra Fields” section at the end, in full paragraph format. This allows users to:
- See an overview of the information at the end of the form,
- More easily check for typos, and
- Ensure that all the necessary information was provided without scrolling back and forth through the small input boxes.
2) Split view of form while drafting
The form can be viewed in a split screen. This allows you to:
- On one side of the screen: populate the small/cumbersome form fields.
- On the other side of the screen: see the duplicated text being populated at the bottom of the form.
Why? When filling out the MIR form, users type long explanations (e.g., incident descriptions or root cause analyses) into small text boxes, where only 4-5 lines are visible at a time. While the form now automatically copies this text to the bottom of the PDF, users must scroll down 10-15 pages to review the content, then scroll back up to make edits.
Therefore, using split view allows you to populate the small/hard to navigate form fields on one side of the screen, and see what is being typed, in full, on the other side of the screen.
What changed in the MIR help text?
The help text has been updated to add two new sections.
Section 6: List of extra fields (all the fields that will displayed at the end of the MIR): This section identifies all the fields that will be duplicated at the end of the MIR form.
Section 7: Guidance for splitting the MIR PDF with Adobe Acrobat: This section explains how to view the MIR form in split screen.
Switzerland Adoption of MIR 7.3.1
Swissmedic has adopted the updated MIR Form 7.3.1 (SB-10791): HERE
And its use will also become mandatory starting Friday May 1, 2026.
