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Informational MDCG 2019-5 Registration of legacy devices in EUDAMED

yodon

Staff member
Super Moderator
#2
Maybe it's just me but I'm confused.

Item 1 in the annex says:

Legacy devices ... should be registered in Eudamed without a Basic UDI-DI and UDI-DI.

But what if the device already has a UDI; i.e., something already being marketed in the US that requires a UDI? Will it still be required that, for these devices, a Eudamed DI and ID will be needed?

My understanding (and maybe I was quite wrong) was that when you had a registered UDI (e.g., for a device in the US), that UDI would be appropriate for Eudamed. Or is there a requirement for a Eudamed-specific UDI?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#3
But what if the device already has a UDI; i.e., something already being marketed in the US that requires a UDI? Will it still be required that, for these devices, a Eudamed DI and ID will be needed?
They are talking about the EU UDI, which may or may not be the same as the US UDI.

My understanding (and maybe I was quite wrong) was that when you had a registered UDI (e.g., for a device in the US), that UDI would be appropriate for Eudamed. Or is there a requirement for a Eudamed-specific UDI?
Nope, they are not automatically the same. But there's expectations that they will be aligned (see - EU interesting developments – embracing MDSAP and UDI alignment).
 

yodon

Staff member
Super Moderator
#4
If a (legacy) device has a "US UDI" and assuming there is alignment with "EU UDI" - would you still be required to enter in Eudamed WITHOUT the UDI and get a Eudamed UDI?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#5
If a (legacy) device has a "US UDI" and assuming there is alignment with "EU UDI" - would you still be required to enter in Eudamed WITHOUT the UDI and get a Eudamed UDI?
There's nothing on that front yet, unfortunately. The way the information is now, yes, the would need to enter without the UDI.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#6
:topic:
The EU will take steps to make use of single audit reports* (an initiative of the International Medical Device Regulators Forum – IMDRF) in a manner that is compatible with EU legislative requirements.
What steps? Timeline?


________________
*) MDSAP
 

Ronen E

Problem Solver
Staff member
Super Moderator
#7
If a (legacy) device has a "US UDI" and assuming there is alignment with "EU UDI" ...
That's a big assumption...

My guess is that no one can reliably answer your question right now; I'm also guessing that if such alignment is achieved in the future*, EUDAMED will accept the US UDI without any extra steps. Otherwise, what's the point of the "alignment"?...

*) When? Who knows?... Let's see first that EUDAMED is up and running as planned, in itself...
 
#9
To my feeling UDIs must relate to devices not to regulations. If UDIs differ from one continent to the other what is the matter of a Unique Device Identification?
We have UDIs in place for 2 years now and I do not understand why we could not use them in EUDAMED no matter if our MDs are lecacy devices or not. The fact that they are certified according to MDD or MDR does not make them different!
 

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