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Case B: Device-related NCAR

  1. Select the Device-related NCAR category in the first field:

    EUDAMED Category of NCAR drop-down list

  2. Select Yes or No in the Manufacturer field, as shown below:

    EUDAMED Yes or No question: Is the MF registered in EUDAMED

    If you answered Yes, you have to select the Actor ID/ SRN from the drop-down that will appear and, if applicable, fill in the Authorised Representative fields:

    EUDAMED drop-down list for Actor ID/SRN
    NCAR_Dev_Related_AR.png

    If the Manufacturer is not registered, fill in the MF information manually:

    EUDAMED NCAR: MF info section

  3. Click on the plus sign next to Device identifier and provide the device reference:

    Example for EUDAMED-registered device (including Old/Custom-made devices):

    EUDAMED Device-related NCAR: Device identifier

    Example for non-EUDAMED-registered device:

    EUDAMED Device-related NCAR: Device identifier for non-registered device

    Note

    In case of a special device (requiring a Master UDI-DI), an additional GTIN field will appear in the Device information section for you to fill in:

    EUDAMED Device-related NCAR: GTIN field

  4. Provide any useful and relevant comments under Additional information:

    EUDAMED additional information: Comments, Background information, Conclusions, Recommendations.

  5. Click on Browse under Related documents to attach any documents relevant to the information provided:

    EUAMED browse button for document attachments

  6. Complete this section by ticking the impacted country(/-ies), the Competent Authorities of which will be notified about this NCAR:

    EUDAMED list of impacted countries

  7. Submission:

    Submit the report by clicking on the blue Submit button on the top right corner:

    EUDAMED Submit button

  8. Finalise the submission of the report by clicking on Complete action in the pop-up window:

    EUDAMED pop-up window with Complete action button and alternative Close button.