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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 to the previous question, you have to select the Actor ID/ SRN from the drop-down list in the field that will appear below:

    EUDAMED drop-down list for Actor ID/SRN

  3. Specify if the Manufacturer has an Authorised Representative:

    EUDAMED Yes or No question: Does the MF has an AR?

  4. Provide the Device information below:

    EUDAMED Yes or No question: Is the device registered in EUDAMED UDI/Device module? and UDI-Di reference selection field

    If you answer Yes, provide the UDI-DI of the device.

    If you answered No to the above question, fill in the information in the appearing fields including Applicable legislation, Risk Class etc., as shown below:

    EUDAMED Device information fields: Applicable legislation, Risk Class, Device trade name, EMDN nomenclature code, Nomenclature device description with intended use and Device description.

  5. Provide any useful and relevant comments in the description fields under Additional information:

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

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

    EUAMED browse button for document attachments

  7. 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

  8. Submission:

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

    EUDAMED Submit button

  9. 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.