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Getting started

Prerequisites to access EUDAMED:

EU Login (ECAS) account

If you do not have an EU Login account, please follow the instructions for creating an account.

To be able to access the Clinical Investigation/Performance Study (CI/PS) module, your organisation needs to be registered as a Sponsor.

Note

If you need to request access for a registered Sponsor, you will find the relevant information on how to register in the Users and Users access management. See EUDAMED Economic Operator user guide Section Users and user access management.

If your organisation is not yet registered as a Sponsor, follow the steps described below.

Click on the following link to arrive to the EUDAMED Playground page

You will be prompted to enter EUDAMED via your EU Login account.