Our most comprehensive support package. Get 20 expert EUDAMED support incidents — ideal for large device portfolios, complex registrations, or organisations going through their first full EUDAMED submission cycle.
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Each incident covers one distinct EUDAMED issue. With 20 incidents you have the coverage for a full submission project.
We investigate your specific error messages, registration rejections, or submission failures and provide a clear resolution path.
Actor Registration, UDI-DI submissions, certificate additions, SRN setup, device amendments — we cover every EUDAMED module.
Send us your issue with screenshots, error messages, or XML files. Our specialists respond with clear guidance within 1 business day.
Incidents cover both MDR 2017/745 and IVDR 2017/746 EUDAMED submissions — including legacy device transitions.
We review your templates, spreadsheets, or XML files and identify exactly what needs to be corrected before resubmission.
Ideal for manufacturers with multiple device types, legacy transitions, and large UDI-DI submission volumes.
Complete your purchase. You'll receive a confirmation email — reply to it to submit your first incident, or save it for when you need us.
Email us with a description of the problem. Include screenshots, error messages, EUDAMED output files, or XML data — the more detail, the faster we can help.
Our EUDAMED specialists review and respond with clear, actionable guidance — typically within 1 business day. Each resolved issue uses one incident.
Companies with many UDI-DIs to register who need ongoing support as they work through their EUDAMED submission backlog.
Manufacturers migrating MDD/AIMDD devices to MDR before the 2027 deadline need sustained EUDAMED guidance.
Acting on behalf of multiple manufacturers means multiple Actor Registrations and SRN setups — support for every step.
Organisations who need to complete their EUDAMED setup before the 28 May 2026 mandatory date and want expert backup throughout.
Ideal for smaller manufacturers or occasional EUDAMED guidance needs.
Best value — for complex portfolios and sustained EUDAMED support.
Buy your 20 Incident Package now and have expert backup throughout your EUDAMED submission journey.
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