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Add a device

Is the Basic UDI-DI known?:

EUDAMED add a device and remove this device links in the devices page and save, save and next and cancel buttons

CASE A: The Basic UDI-DI is known

  1. Select Yes in the field Is the Basic UDI-DI known?:

    EUDAMED add a device and remove this device links in the devices page and save, save and next and cancel buttons

  2. Enter part/all of the Basic UDI-DI code and click on the Check registry button. Only devices that are eligible for this type of procedure or certificate, and only those related to the manufacturer, will appear.

    EUDAMED enter the basic udi-di code and check registry button in the devices page

    • If the device is already registered in EUDAMED, then select the device from the list:

      EUDAMED list with registered devices with pagination, next and close buttons

    • Otherwise, if the device is not yet registered in EUDAMED, click on the Enter data manually button:

      EUDAMED informational message and enter data manually and cancel buttons

      Select the Issuing Agency and the risk class of the device and specify if the device is implantable or not (property applicable only for MDR):

      EUDAMED basic udi-di, issuing agency, risk class and implantable fields in the devices page

      Specify if the device model is applicable or not:

      EUDAMED device model applicable toggle button, device name and name fields in the devices page
      EUDAMED device model applicable toggle button and name field in the devices page

  3. Add some characteristics of the device:

    EUDAMED drop down list in the codes field in the device type section
    EUDAMED drop down list in the codes field in the device type section

  4. Add a description of the purpose:

    EUDAMED add the indented purpose field in the indented purpose section

  5. Click Save or Save and Next.

  6. For additional devices, click + Add a device.

CASE B: The Basic UDI-DI is not known

  1. Select No in the field Is the Basic UDI-DI known?:

    EUDAMED add a device and remove this device links in the devices page and save, save and next and cancel buttons

  2. Identify the device by Name or alternatively, provide the Reference/Catalogue number in free-text and select the Risk Class. Note the Name or Reference/Catalogue number options also apply when registering Refused/withdrawn applications:

    EUDAMED is the basic udi-di known and provide one of the below fields and remove this device link
    EUDAMED enter reference/catalogue number and risk class fields, remove this device and add device links and save and cancel buttons

  3. Provide the device type and the intended purpose:

    EUDAMED codes according to the device type and horizontal codes drop down lists
    EUDAMED add the indented purpose field

  4. Click Save or Save and Next.

  5. For additional devices, click + Add a device.