Case A: Device with identifier registered in EUDAMED
If the device identifier is known, answer Yes to the question Does the device have a known identifier? and type the device identifier in the Device Identifier field below:
The system will retrieve the device's details:
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:
Specify the Device Nomenclature code:
Select the regulatory scope of the device:
Describe the device and its intended purpose:
Fill in the UDI Production Identifier section:
Fill in the Device dates section:
In the Certificate Identification section, click on the plus sign to add the NB certificate number:
Type the NB ID number and select it from the dropdown list (click on Add for more than one certificates):
Note
The Certificate Identification fields will vary slightly depending on the type of device selected; in some cases the user will enter data manually and in others the system will auto-fill the data.
In case of an implantable device the system will prompt you to fill in the relevant section:
Under Market Distribution, select the country(-ies), in which the device is made available:
