On May 5th, 2025, the European Commission (EC) released the Manufacturer Incident Report (MIR) version 7.3.1. This updated form is a cornerstone in the EU’s post-market surveillance (PMS) system for reporting serious incidents and field safety actions related to medical devices and in vitro diagnostic (IVD) devices. The aims are to harmonize vigilance reporting, enhance global surveillance compatibility, and improve data quality and transparency.
The update is mandatory for all manufacturers of medical devices operating in the EU, and it has implications for related vigilance processes in the UK and Switzerland. The MHRA has not yet announced changes to its reporting form, but alignment is expected in the future.
Transition period: The use of MIR version 7.3.1 is optional until November 2025[1]; after this date, it will become mandatory in both the EU and Switzerland.
Key Changes in EU MIR 7.3.1
The new MIR version 7.3.1, published in July 2025, includes several significant changes compared to version 7.2.1:
Main Updates:
|
Change |
MIR 7.3.1 Section |
Description/Verification Point |
|
Separate Dates: Incident Awareness vs. Reportability Awareness |
Section 1.2.e – Type of Report |
This distinction implements MDCG 2023-3 guidance (Q15). It was not present in MIR 7.2.1. |
|
Mandatory Use of IMDRF Codes (Annex E, F, G) |
Section 3.3 – Clinical Information |
IMDRF codes are now compulsory for clinical effects (E), health impact (F), and components (G). For unused component fields, (“Not applicable”). |
|
UDI Issuing Entity Identification |
Section 2.1 – Unique Device Identification (UDI) |
A dropdown menu for UDI-issuing entities has been introduced. This was not required in 7.2.1. |
|
Separate Device Description and Nomenclature Fields |
Section 2.3.a – Device Name |
MIR 7.3.1 separates product name and intended use/nomenclature, whereas 7.2.1 combined these. |
|
Legacy Device Reporting & Applicable Legislation |
Section 2.4 – Risk Class and Regulatory Status |
Allows marking the device as legacy, plus an option to select “Unknown” for applicable legislation if needed. |
|
Combination Products / EMA Consultation Fields |
Section 2.4.e/f – Medicinal Substance or Tissue Association |
Added to reflect situations where EMA consultation or expert panel review is involved for drug-device or tissue-device combinations. |
|
Market Distribution Update |
Section 2.5 – Market Distribution of Device |
Great Britain and Switzerland removed; Northern Ireland (XI) added. This change aligns with Brexit and Swiss regulatory independence. |
|
Similar Serious Incidents – EEA + Turkey + XI |
Section 4.3.3 – Similar Incidents |
Statistical calculations now exclude Switzerland but include the EEA, Turkey, and Northern Ireland (XI). |
|
XML File Handling Enhanced |
Form Metadata / Submission Options |
XML can now be directly saved from the form, not just sent by email. This supports better integration with internal systems. |
|
New Help Text with Supplementary Resources |
Separate Help Document (available from EC site) |
The new help text includes links to IMDRF AE and EMDN databases, expanding guidance compared to previous versions. |
UK, NI, and Switzerland
Although MIR 7.3.1 is an EU-specific form, the UK and Swiss markets have their own vigilance requirements. However, the underlying expectations are closely aligned.
United Kingdom (UK):
- The MHRA (Medicines and Healthcare products Regulatory Agency) requires incident reporting for devices placed on the market in Great Britain.
- The UK uses a separate Manufacturer Incident Report form, but the content and structure are largely based on the MIR 7.2.1 format.
- The MHRA is currently updating its reporting systems. Manufacturers should anticipate alignment with new EU fields, especially for combination products and trend reporting.
- Online reporting via the MHRA More portal remains mandatory for UKCA-marked devices.
- Deadlines differ from the EU:
- Death or unanticipated serious deterioration: 10 days
- Other serious incidents: 15 days
Northern Ireland:
- Devices placed on the Northern Ireland market (XI) must comply with EU MDR/IVDR vigilance rules, including the use of MIR 7.3.1.
- Reports must be submitted to both the MHRA and the relevant EU Competent Authority.
Switzerland:
- The Swissmedic vigilance system requires incident reporting under the MedDO (Medical Devices Ordinance) and IvDO (IVD Ordinance).
- Swissmedic accepts reports in the MIR format, and currently still allows the use of MIR 7.2.1. However, MIR 7.3.1 is recommended for forward compatibility.
- Reports must be submitted directly to Swissmedic, not via EUDAMED.
- Deadlines are aligned with the EU MDR/IVDR:
o 2 days for serious public health threats
o 10 days for death or unanticipated serious deterioration
o 15 days for other serious incidents
- Swiss CH-REP (Swiss Authorized Representatives) play a mandatory role in the reporting chain for non-Swiss manufacturers.
Why Is This Important?
Whether you are marketing devices in the EU, UK, or Switzerland, vigilance compliance is not optional. Regulatory authorities expect:
- Immediate awareness of incidents
- Structured reporting using the correct forms
- Digital submissions compatible with evolving systems (EUDAMED, MHRA portals, Swissmedic)
- Timely root cause analysis and corrective actions
Transition Period and Next Steps
|
Current Status |
Next Steps |
|
MIR 7.2.1 and 7.3.1 accepted until November 2025 |
All manufacturers must fully transition to MIR 7.3.1 by November 2025. |
|
Swissmedic and EU acceptance confirmed |
CH guide compliance is required for Swiss reporting. |
|
EUDAMED compatibility pending |
A new version of MIR is likely to be issued for mandatory use in EUDAMED in the future. |
How QNET Can Help
We provide:
- MIR 7.3.1 reporting support for the EU market
- UK vigilance reporting via the MHRA More portal
- Swissmedic vigilance submission guidance
- Authorized Representative (EAR, UKRP, CH-REP) services
- Post-market surveillance and vigilance process management
[1] https://health.ec.europa.eu/document/download/e8ce9f53-82cb-44c8-a06e-91ad71c16b01_en?filename=md_new-reg_mir-form-v7.3.1_en.pdf