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Step 0: Old/custom-made device registration

  1. On the dashboard, click on Register an old/custom-made device.

  2. Select the applicable legislation:

    EUDAMED applicable regulation field
  3. If a UDI-DI is assigned, toggle the button to Yes and provide the Issuing Entity and the UDI-DI code:

    EUDAMED issuing entity and udi-di code fields

    If a UDI-DI is not assigned, toggle the button to No and enter the Device code. Then click on the Generate button:

    EUDAMED device code field and generate button
  4. The Device identifier will be displayed. Click on Save & Next to continue:

    EUDAMED device identifier and save and next button