Eudamed.com have created a free template for end-users to create their “EUDAMED DI Generated” Basic UDI’s and UDI DI’s for use with their legacy devices when entering data into EUDAMED. These generated codes should not be confused with issuing entity generated UDI DI codes, these are considered EUDAMED generated codes only for devices that do not have existing UDI DI codes and will be added to EUDAMED. This template is based on the European Commissions publication on “Legacy Device Management”
Version 3 allows for the creation of EUDAMED IDs and EUDAMED DIs using SRN and up to 8 character manufacturer code, OR with no SRN using only the manufacturer codes of up to 21 characters in length. Note: This could result in a duplicate code if another manufacturer uses the exact same code.
Please complete the following to receive the free template. Please avoid using free email accounts like yahoo, hotmail, gmail, etc. these will not receive the emailed template.
Update: The European Commission made a small change to the tables used for the calculations, this required us to update the template. Version 2 is now available for download.
Question(s) we received about the template:
Q: What is a legacy device, EUDAMED DI code?
A: The legacy device is a directive device, a device certified under MDD, IVDD or AIMDD. The EUDAMED DI is a code that is used when the device does not have an existing UDI ID. It is a ‘fake’ UDI DI used only when registering your device in EUDAMED and only for legacy or directive devices that do not have an existing UDI DI.
Q: What is the difference between the EUDAMED DI and the EUDAMED ID?
A: The EUDAMED DI is the equivalent of the Basic UDI and the EUDAMED ID is the equivalent of the UDI DI. These generated codes are only for use in EUDAMED, these are not for reporting or for labels, only for registering directive devices in EUDAMED that do not have an existing UDI DI.
Q: We use a tool from GS1 to create our DI / GTINs.
A: This free ‘legacy device’ tool is only used for devices that do not already have UDI DI’s assigned from an issuing entity like GS1. This tool is for the creation of essentially “fake” EUDAMED ONLY DI’s used only when registering legacy devices in EUDAMED.