This resource is the English version of the EUDAMED (European Database on Medical Devices) User Guide for Economic Operators published by the European Commission.
About this document
EUDAMED is the EU medical device database established under the MDR and IVDR. Manufacturers, authorised representatives and importers must register their actor roles in it, obtain a Single Registration Number (SRN), and progressively enter UDI (Unique Device Identification) and device information. The guide explains step by step how to apply for an account, register actors and enter data.
Applicable products and users
- Manufacturers placing medical devices / IVDs on the EU market
- EU authorised representatives, importers, and system and procedure pack producers
Main contents
- EU Login accounts and the actor registration process
- Applying for a Single Registration Number (SRN)
- Data entry in the UDI / device registration module
- User access management
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Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.