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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).
 

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...
 


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