Getting started
What I need to access EUDAMED:
To use EUDAMED, you must have an EU Login account associated with your professional email address and the manufacturer for which you want to act on behalf must be registered as an actor in EUDAMED.
2. User profile registration in EUDAMED
For information on how to gain access to EUDAMED, please consult the Economic Operators user guide.
Note
EUDAMED is also available in a Playground environment, intended to enable you to experiment with the application. All the information in this environment is dummy (including the Actor ID/SRN) and will never be moved to the Production environment. Access to the Playground requires a separate registration.
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Every user in EUDAMED is granted by default the profile Viewer for the UDI/Device module, and can search and view registered devices. However, to enter UDI/Device data in EUDAMED, you must request access for the UDI/Device module with a higher profile [1] as either:
A Proposer – this profile allows you to create and delete draft records related to your manufacturer, or
A Confirmer – this profile includes the Proposer rights and additionally, allows you to submit and discard records.
Note
See the Economic Operators user guide, Section Upgrading your user profile for further information on how to upgrade your profile from Viewer to Proposer or Confirmer.
Important
A Local Actor Administrator (LAA)/Local User Administrator (LUA) of your manufacturer must approve your user access request (If you don't have a second user with LAA/LUA profile, please refer to the Economic Operators user guide, Section Requesting access as a second LAA user to an existing registered actor).
Before you start entering details of a UDI/device in EUDAMED, please ensure you have all the required information at hand, including the Basic UDI-DI and UDI-DI codes. Fields marked with a red asterisk are mandatory.
[1] See the Economic Operators user guide, Section User rights and profiles, for more information on user rights and profiles.