End-to-end MIR and FSCA submission for EUDAMED and MHRA MORE — covering all stages, all deadlines, for both EU MDR / IVDR and UK regulatory requirements.
Serious Incident — MIR Required
Death or unanticipated serious deterioration in health
Serious Incident — Initial MIR
Where cause not yet determined
EirMed handles the submission
Structured electronic record in EUDAMED + MHRA MORE
The EU PDF MIR form is being retired.
When the EUDAMED Vigilance module is declared mandatory by the European Commission, electronic submission via EUDAMED becomes the only compliant route for MIR and FSCA reports under MDR 2017/745 and IVDR 2017/746. The legacy PDF MIR form — which has been the standard submission method since the MDD era — will no longer be accepted by National Competent Authorities once this transition is complete.
Four new obligations your team must meet when EUDAMED Vigilance becomes mandatory.
Structured electronic MIR records
Every MIR must be submitted as a structured electronic record in EUDAMED, linked to the device's UDI-DI and SRN. The free-text PDF approach is no longer sufficient.
Automatic deadline tracking
15-day deadlines (death / unanticipated serious deterioration) and 30-day deadlines (other serious incidents) must be tracked automatically — not manually. A missed deadline is a regulatory non-compliance.
Audit-ready incident register
An audit-ready incident register with NCA acknowledgements must be maintained electronically and be available for inspection at any time.
Linked FSCA and follow-up reports
FSCA and FSCA Follow-up reports must be linked to the original MIR in EUDAMED, creating a complete and auditable field safety action record.
We handle every stage of the MIR and FSCA process for both EUDAMED and MHRA MORE — so your team meets deadlines and stays audit-ready.
We manage the complete MIR lifecycle: initial report, 30-day follow-up, and final report. All submitted directly via EudaMed+ M2M as structured electronic records linked to your UDI-DI and SRN.
Field Safety Corrective Action reports and FSCA Follow-up submissions handled end-to-end. We ensure each FSCA is correctly linked to its originating MIR in EUDAMED, maintaining the complete audit chain required by MDR and IVDR.
Submission to the MHRA's Medical Device Online Reporting and Evaluation (MORE) system for UK market obligations. We manage both EU EUDAMED and UK MORE submissions — one point of contact, both jurisdictions covered.
Incident Reported
Your team upload a MIR or FSCA spreadsheet or JSON file.We validate the data meest the EUDAMED/MORE requirements.
We Prepare the MIR
After validation We compile the structured MIR in the correct EUDAMED XML format, linked to the device UDI-DI and SRN. For UK incidents we prepare the MHRA MORE submission simultaneously.
Submission & Acknowledgement
We submit directly to EUDAMED and / or MHRA MORE and obtain system reference numbers used by the relevant NCA. You receive confirmation with reference numbers and a copy for your incident register.
Follow-up & FSCA
We manage all follow-up reports and final MIR closure. Where a Field Safety Corrective Action is required, we prepare and submit the FSCA and any follow-up FSCA reports, linked to the original MIR.
Audit-Ready Register
Every submission, acknowledgement and correspondence is recorded in your exportable incident register — audit-ready evidence of your MDR / IVDR post-market surveillance obligations.
The EirMed MIR & FSCA Submission Service is built specifically for this transition. Direct EUDAMED Vigilance submission, integrated UK MHRA MORE parallel submission, automatic deadline alerts, and a full exportable incident register — ready now, before the mandatory date.
Deadlines are unforgiving
15-day deadlines (death / unanticipated serious deterioration) and 30-day deadlines (other serious incidents) leave no room for a manual scramble. You need a process in place before an incident occurs — not after.
EUDAMED electronic format is non-trivial
The structured electronic MIR requires fields mapped to UDI-DI, SRN and EUDAMED actor records. It is not a form you can complete under time pressure without preparation.
UK obligations run in parallel
If you supply both EU and UK markets, you have simultaneous obligations to EUDAMED and MHRA MORE. We manage both.
NCAs will check the register
Audit-ready electronic incident registers with NCA acknowledgements are an active inspection focus across EU NCAs.
Contact our team to discuss your MIR and FSCA requirements for EUDAMED and MHRA MORE. We respond within 1 business day.
No commitment required. We respond within 1 business day.
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