Basic UDI-DI and Legacy Devices

Philip B

Quite Involved in Discussions
#1
Does anyone understand the situation regarding legacy devices and assignment of Basic UDI-DIs? I've created Basic UDI-DIs for our device families which are currently under the MDD. However I've just read a Commission document which states that legacy devices will never have a Basic UDI-DI and need to have a EUDAMED-ID instead. However, does this apply only whilst we are under the MDD and as soon as we transition to the MDR the devices are considered to be new and we will need Basic UDI-DIs?
 
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itscloud

Starting to get Involved
#2
Hi,

Yes, According to MDCG 2019-5 the very last paragraph we'll need new Basic UDI-DI and UDI-DIs if we are compliant with the regulation.

"In case a legacy device has been already registered in Eudamed and that same device becomes at any point in time an MDR compliant device, that MDR device should be considered as a new device requiring a new registration (due to the change in the applicable legislation) with a Basic UDI-DI and UDI-DI in Eudamed. However, only a UDI-DI should be entered, if another device with the same Basic UDI-DI has already been registered. Eudamed should facilitate this (copy) process and allow the linking between the MDR device and the corresponding legacy device. "

Does anyone knows when the UDI module would be up in the Eudamed? I heard it's coming this September

Thanks
Cloud
 

Philip B

Quite Involved in Discussions
#3
Thanks Cloud. Since I posted I now understand that the legacy device aspect only applies whilst we are under the MDD and when we transition to the MDR they become 'new' devices and need a Basic UDI-DI.

Still September I think for the UDI module.
 

LAM2020

Starting to get Involved
#4
HELLO, I am not sure I understand everythibng. we have legacy device and we have basic udi di and udi-di for all our devices. will that be enough to register in eudamed? please and thanks
 

Philip B

Quite Involved in Discussions
#6
HELLO, I am not sure I understand everythibng. we have legacy device and we have basic udi di and udi-di for all our devices. will that be enough to register in eudamed? please and thanks
If you are still under an MDD certificate you can't register your legacy devices in EUDAMED (this is my best understanding). When you transition to the MDR your devices then become 'new' devices and you can then register them in EUDAMED using your basic UDI Di and UDI DI. As Debbie has mentioned the EUDAMED device module isn't available yet.
 

debbie gallagher

Starting to get Involved
#7
Agree Philip, but if you report a serious incident or a Field Safety Corrective Action with a legacy device, that device has to be registered in EUDAMED
"immediately"
 

Philip B

Quite Involved in Discussions
#8
Agree Philip, but if you report a serious incident or a Field Safety Corrective Action with a legacy device, that device has to be registered in EUDAMED
"immediately"
Yes, agree and in that case EUDAMED assigns you a EUDAMED-ID and EUDAMED-DI as you can't use your MDR Basic UDI DI and UDI DI.
 

kormach

Starting to get Involved
#9
Hi,

I also have a question regarding this topic. Maybe someone will help me now when the UDI module is ready:
Can we have the UDI on the label if we are still under MDD certificate?
We will of course assign EUDAMED DI and use our UDI-DI to create the EUDAMED ID in the database.
Does anyone has an experience with this?
 

Philip B

Quite Involved in Discussions
#10
As far as I am aware there is nothing to stop you adding UDI to your labelling under the MDD. We have had it on our labels for four years now under the MDD. UDIs issued by an approved issuing entity can be used for other purposes than regulatory compliance, for example, UDIs issued by GS1 (GTINs) are needed in the UK to comply with the NHS Scan4Safety scheme.
 
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