April “In All Other News”: Master UDI-DI Effective Date Postponed, IVD Q&A Progress, and More
2 May 2025
Swissmedic Publishes New Manufacturer Incident Report (MIR) Form and Guidance Document
12 May 2025Background
What is the MIR Form?
The Manufacturer Incident Report (MIR) form was created by the European Commission. It is a standardized way for manufacturers to notify the relevant competent authorities of serious incidents that occurred in Europe.
Why was the MIR Form revised?
The MIR form was revised to account for additional requirements under the MDR/IVDR, including legacy devices. The previous version of the PDF form was last updated in 2019.
Overview of New MIR Form
Where to Find the Updated MIR Form v7.3.1
The new form is available: HERE
The other vigilance documents, such as the Field Safety Corrective Action (FSCA) form, are also now available in the above link. Some of these older documents are in the process of being revised, such as the Manufacturer Trend Report form, which, as of October 2024, was in the final stages of development.
Casus has updated its resource: Links to Regulations & Guidance Documents
Mandatory Use Date
There is a six (6) month transition timeframe, i.e., MIR Form 7.3.1 becomes mandatory starting November 2025.
The Commission will keep MIR Form 7.2.1 available for six months, as advised here. This is to allow sufficient time for 1) economic operators to amend their processes and documentation, and 2) national Competent Authorities to adapt their internal systems.
Once the EUDAMED vigilance module is fully functional, the PDF version of the MIR Form should no longer be needed.
Differences Between the Old & New MIR Form
The full change log is available: HERE
Notable changes include:
- Section 1.2: now includes “Manufacturer awareness date of reportability”, which is the date in which the manufacturer received the information that determined the incident is reportable.
- Section 2.1: now includes dropdowns to identify the UDI issuing entity, if applicable.
- Section 2.4: now includes sections to note if the applicable legislation is unknown, if the device continued to be placed on the market after the MDR/IVDR date of application, and if MDR Art. 52(9), MDR Art. 52(10), IVDR Annex IX Section 5.2, or IVDR Annex X Section 3.k are applicable.
- Section 2.5: updated to remove Switzerland and add Northern Ireland.
- Section 4.1: now includes the question “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?”
MIR Form Guidance
The Commission’s Help Guide is available on the same new webpage as the MIR Form. Specifically, you can access it by clicking: HERE
Additional Resources
The following items may also be of interest:
