Device information
Under the Device information section, start by selecting the regulatory scope type:
Select the type of device scope:
Important
Depending on the type of device scope selected, the process will vary slightly, as shown in each of the four options below.
Follow Option A, B, C or D
A. Category/Type/Group from Medical device nomenclature (EMDN):
For the Category/Type/Group from Medical device nomenclature (EMDN) option, you must select the applicable legislation(s):
Depending on the applicable legislation(-s) selected, different Risk Class and Device type values will be displayed.
Fill in the fields Device Nomenclature Code and Nomenclature text accordingly:
Example with AIMDD as applicable legislation:
Example with MDD as applicable legislation:
Example with MDR as applicable legislation:
To add more nomenclature codes, click on the Add button.
B. Basic UDI-DI(s)/EUDAMED DI(s):
Enter the Basic UDI-DI/EUDAMED DI:
Click on Add to add more Basic UDI-DI(s)/EUDAMED DI(s).
C. UDI-DI(s)/EUDAMED ID(s):
Under Device details, click on the plus sign next to Device identifier to select one or more UDI-DIs/EUDAMED IDs:
Click on Add to add more devices if necessary.
D. UDI-DI and UDI-PI(s) / EUDAMED ID(s) / Device name and Lot/Batch Number(s):
Click on the plus sign next to Device identifier to select one UDI-DI:
Next, upload the UDI-PI:
Alternatively, enter the Production Identifier information manually:
Select the Notified Body ID number and enter the Notified Body certificate number manually:
Click Add for multiple entries.