EUDAMED Registration, Handled From Your Own Excel Data
Every medical device placed on the EU market now needs to be registered in EUDAMED — the European database that replaced the patchwork of national registration systems under the old directives. For manufacturers, that means submitting structured product, UDI, and device data in a specific XML format, correctly matched to the applicable rule set for MDR or legacy (MDD/AIMDD) devices.
Most manufacturers already have this data — in Excel, in an ERP export, or in some internal tracking sheet — but EUDAMED doesn't accept raw exports. It requires validated, schema-compliant XML, submitted through the Bulk Upload function or entered manually, device by device.
EUDAbridge handles the conversion step: your existing Excel data goes in, EUDAMED-ready XML comes out, with every field checked against EUDAMED's own business rules before you submit anything. Built specifically for manufacturers who don't have — and don't want to hire — a dedicated regulatory software team just to get through registration.
How it works
Start from your own data
Excel in, no need to learn EUDAMED's schema or reformat everything from scratch.
MDR and legacy device coverage
One tool, correct rule set applied automatically based on device type.
Validation before submission
Catch missing or incorrectly formatted fields before they become a rejected batch.
Auto-mapping for non-standard spreadsheets
Works with the column structure you already have, not just a rigid template.
You submit, on your terms
Final XML and EUDAMED submission stay in your own account; nothing is filed on your behalf without your review.
FAQ
What is EUDAMED registration?
EUDAMED registration is the process of submitting medical device, UDI, and manufacturer data to the EU's European Database on Medical Devices, required for devices placed on the EU market under MDR, and for legacy devices under a separate deadline.
Do I need a consultant to register in EUDAMED?
Not necessarily. Registration requires structured, validated data — manufacturers with the right tooling can prepare and submit this themselves, without a third-party consultant, though consultants remain a valid option for teams without internal capacity.
How long does EUDAMED registration take?
This varies by catalogue size and data readiness, but the most time-consuming part for most manufacturers is formatting and validating data correctly — not the submission itself.
Looking for something more specific?
EUDAMED Bulk Upload
Automatic batching into EUDAMED's 300-entity limit, for manufacturers registering more than a handful of devices.
EUDAMED Legacy Devices
Legacy-specific validation for MDD/AIMDD devices, ahead of the 27 November 2026 deadline.