If you use a UDI DI for your directive or legacy devices, MDD and IVDD, EUDAMED allows you to reuse this same UDI DI when this device transitions to MDR and IVDR. Fact.
When you add a new regulation device using a UDI DI that was already used for the same legacy device you receive the following prompt from EUDAMED.
There has been some confusion around this point because EUDAMED does match the legacy device data against the newly added regulation device data to make sure the data is the same. Some of the confusion comes from the warning itself which says the properties must be identical. The properties mean mostly Boolean data fields entered for the legacy device data. This is important to understand, this warning does not mean the risk class.
Increasing the risk class when transitioning from MDD to MDR was recently cited as a reason not to enter legacy devices. Based on my experience with EUDAMED and the internal European Commission meetings we had regarding adding legacy devices to EUDAMED I did not believe this should be an issue. Just to be safe I contacted the European Commission to clarify this point and this was their response
“The new class will not block reusing the UDI-DI when linking a Legacy with an MDR device having the same UDI-DI.”
The risk class change is no reason not to submit legacy devices.
Why enter legacy devices?
Firstly there are two legal reasons to enter the legacy devices
- A post-market surveillance and/or a vigilance report ensues after EUDAMED is fully functional; or
- By the end of the transition period applicable for device registration, if no equivalent MDR or IVDR device is registered in EUDAMED
There is one more major reason (in our opinion) to enter the legacy device data and that’s the market history of the device.
For example, if your MDD device is successfully on the market for 10 good years then your MDD “Market Start Date” is 10 years ago, this date field is one of the many EUDAMED requirements. When you transition to MDR your “Market Start Date” is the day you first put it on the market after you receive your MDR certification. If you only enter the MDR data then your device is new with no history, this could make marketing harder to places that do not know your product. However, if you also enter the MDD data, EUDAMED links the same UDI DIs, MDD and MDR, then the history of your product starts 10 years ago. This, in our opinion, is a good marketing opportunity, it allows you to show your successful market history right from the MDD/IVDD start date.
One thing that you should also take note of is if adding the legacy devices to EUDAMED does not fit with your strategy, and will cause you too much stress then quite simply, don’t do it. Other than the two legal requirements it is voluntary.
I hope this helps clear up some confusion.
You can find everything you need from training to UDI submission software and support on our site Eudamed.com Please do contact us about our products and support, we are here to support you.