Skip to main content

Device information

  1. Click on the Device Information section from the menu on the left:

    image109.png

  2. Click on the plus sign next to Device details to access the fields to be filled:

    image110.png

  3. Select the applicable legislation:

    image111.png

  4. Specify if the device is custom-made:

    image112.png

  5. Provide the UDI-DI:

    image113.png

  6. Select the EMDN nomenclature code:

    image114.png

    The system will auto-fill the Nomenclature text field:

    image26.png

  7. Describe the device and its intended purpose:

    image26.png

  8. Answer the next question with Yes or No:

    FSCA_scientific_opinion1.png

    Important

    The mandatory field regarding a scientific opinion above will only appear for MDR and IVDR legislations.

  9. Click on Browse to upload a UDI PI Document in PDF format:

    image116.png

  10. Click on the plus sign next to Certificate Identification and complete the appearing fields:

    image119.png

    Select the Notified Body details from the drop-down list and insert the NB certificate number for the device.

  11. Select the appropriate Device date and fill in the year and month:

    FSCA_date.png

  12. Tick the countries where the device is made available on the market:

    MIR_Market_distribution_countries.png

  13. Provide information for the Associated Devices and Device Accessories section:

    image122.png