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Register a withdrawn application

vid-icon.jpg VIDEO: Register a withdrawn application

Click Register a withdrawn/refused application in the Applications/refused certificates section:

EUDAMED register a withdrawn/refused application on the dashboard

  1. Select what you want to register:

    EUDAMED what do you want to register field

  2. Select the applicable regulation, in this case IVDR, and then select the conformity procedure:

    EUDAMED applicable regulation field and conformity assessment procedure fields

  3. Provide the Application reference number, the Decision date and the Date of submission by:

    EUDAMED application reference number, decision date and date of submission by fields

  4. Enter the Actor ID/SRN or name of the manufacturer or the system/procedure pack producer, click Find and select from the list displayed:

    EUDAMED enter actor id/srn or name field and find button

  5. Click Save & Next:

    EUDAMED details on the selected manufacturer and save and next button

  6. The process flow displays. First add the Decision language(s). You can select multiple languages, then click Select:

    EUDAMED add languages field and provide certificates language pop-up window

  7. The language tabs display, which can be removed using the x. Click Save & Next:

    EUDAMED decision languages selected, remove all and add more languages link and save, save and next and cancel buttons

  8. The next step in the flow is Add a device group:

    EUDAMED add a device group link and save, save and next and cancel buttons

  9. Enter the device group identification and select the risk class. Click Save & Next:

    EUDAMED identification of the device group and risk class fields

  10. Add a device. Click + Add a device:

    EUDAMED add a device link and save, save and next and cancel buttons

  11. Select Yes or No in the field Custom made class III implantable and specify if you will provide the Name, the Reference/Catalogue number or the Basic UDI-DI of the device:

    • If you select the Name, then you must provide the Name and the Risk class of the device:

      EUDAMED provide one of the below, name and risk class fields

    • If you select the Basic UDI-DI, then you must fill in the field Enter the Basic UDI-DI code and click the Check Registry button:

      EUDAMED enter the basic udi-di field with check registry button, remove this device and add a device links

      In the pop-up window either select the device from the list (if the device is already registered in EUDAMED) or click on the Enter data manually button (if the device is not yet registered in EUDAMED) to add the Basic UDI-DI manually:

      EUDAMED list with basic udi-dis, pagination and enter data manually and cancel buttons
      EUDAMED enter the basic udi-di field with check registry button, remove this device and add a device links, save, save and next and cancel buttons

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

      EUDAMED basic udi-di, issuing agency, risk class and implantable fields

      Specify if the device model is applicable or not:

      EUDAMED device model applicable toggle button to yes and device model and name fields
      EUDAMED device model applicable toggle button to no and name field

  12. Click Save & Next.

  13. The reasons for the withdrawal/refusal in the language indicated above the text box. You can click Preview to double-check the content in each step:

    EUDAMED reason for the withdrawal/refusal comment and save, preview, submit and cancel buttons

    1. Scroll through the preview. You can return to a specific step by clicking Go back to step x to make edits:

      EUDAMED preview full registration for submission page
      EUDAMED go back to step 1, 2, 3 and 4 links

    2. If you make edits, click Save & Next, then you will see this confirmation message. Click Yes, and proceed out of any further steps until you reach the last one:

      EUDAMED confirmation window and yes and no buttons

  14. Click Submit my request:

    EUDAMED confirmation window and submit my request and cancel buttons

  15. The Confirmation message displays:

    EUDAMED confirmation message when submitting a registration of a withdrawn/refused application for conformity assessment