EUDAMED
Compliant registration without any headaches

What, who and when must be registered in EUDAMED?

Economic operators

  • Manufacturer
  • EU authorized representatives
  • Importers
  • Producers of systems or procedure packs

…require a separate EUDAMED registration number (SRN) in the actor module for each role, which may already be mandatory depending on the EU member state (e.g. Germany).

Medical devices and IVDs

Each individual product (UDI-DI or REF no.) placed on the market on or after the date of mandatory registration in the EUDAMED product module (planned: early 2026!)requires its own registration with a flood of relevant data that no manufacturer keeps in their ERP system.

Products that are no longer placed on the market at the above-mentioned date may also have to be registered in EUDAMED at short notice

Update in the EUDAMED Database

From now on, changes to the trade register number and the VAT number can be made directly via the Actor Registration account in EUDAMED. This feature was enabled this week as part of a database update. Further changes and details can be found in the document available in our Download section.

Download document
Qualitätsmanagement

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