Global Submission Portal: Now including MIR Reporting (EUDAMED Vigilance)
Finally: Capture, validate, and submit EU Manufacturer Incident Reports centrally – in a single workflow.
The Global Submission Portal is taking the next step: Following the successful launch with FDA eMDR and UDI submissions, we are now adding EUDAMED Vigilance. This means: EU Manufacturer Incident Reports (MIR) can now be handled just as efficiently and securely as all other submissions – no disconnected tools, no chaos.
From FDA to EUDAMED – One Platform, All Submissions
We launched the Global Submission Portal in November with a clear goal: an end to time pressure, error-prone processes, and isolated solutions. FDA eMDR, FDA GUDID, EUDAMED UDI – everything in one system, fully automated end-to-end. Now we are closing the gap: EUDAMED Vigilance (MIR) is live. This allows customers to manage their EU reporting obligations with the same consistency and control as their US submissions.
Why MIR used to be a headache – and how we’re changing that
Anyone who has ever handled an MIR submission knows the drill: scavenging for data from three different sources, manually typing into forms, chasing status updates via email, Excel chaos. The result? Lack of transparency, delays, and high risk of errors. The Global Submission Portal puts an end to this.
How MIR works now – simple, secure, traceable
- Excel Template instead of Freestyle
Capture all relevant data in a structured format – no more guessing what goes where. - Automatic Validation
The system checks for completeness and plausibility before sending – catching errors before they become costly. - Transparent Status Tracking
Every submission goes through clear status steps (Uploaded → Processing → Success/Failed). No more “Did that actually go through?” moments. - Download Center for everything
Result files, protocols, and acknowledgments – collected as a ZIP file or individually, available for download at any time.
One Platform. Global Compliance. Done.
With FDA eMDR, GUDID, EUDAMED UDI, and now EUDAMED Vigilance (MIR), the portal covers the most critical regulatory workflows in one unified solution. No tool-hopping. No duplicate work. Just one system.
Send your inquiry directly here: https://udi.europe-it-services.com/
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