Device information
Click on the Device Information section from the menu on the left:
Click on the plus sign next to Device details to access the fields to be filled:
Select the applicable legislation:
Specify if the device is custom-made:
Provide the UDI-DI:
Select the EMDN nomenclature code:
The system will auto-fill the Nomenclature text field:
Describe the device and its intended purpose:
Answer the next question with Yes or No:
Important
The mandatory field regarding a scientific opinion above will only appear for MDR and IVDR legislations.
Click on Browse to upload a UDI PI Document in PDF format:
Click on the plus sign next to Certificate Identification and complete the appearing fields:
Select the Notified Body details from the drop-down list and insert the NB certificate number for the device.
Select the appropriate Device date and fill in the year and month:
Tick the countries where the device is made available on the market:
Provide information for the Associated Devices and Device Accessories section: