UDI needed when we submit to ON?

LAM2020

Starting to get Involved
#1
hELLO
we are a manufacturer of class IIb devices and we are looking to submit our technical files to an ON according to the mdr 2017/745. one thing I am not sure about is when we have to submit our file do we have to have the UDI on the Labels already in place. Or can we submit our labels without it on it as we do not have anything in place at the time.
Thank you
 
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xcanals_tecno-med.es

Involved In Discussions
#3
Hi
You need to asign the basic UDI-DI and the UDI-DI to the devices which will be evaluated by the NB (from 26 may 2021)
And this information must be included in the technical documentation according annex II of MDR
The use of UDI-DI and UDI-PI in the labelling depends on the classificaction of the devices:
class III - from 26 may 2021
class IIa and IIb - from 26 may 2023
class I - from 26 may 2025
BR
Xavier Canals
 

LAM2020

Starting to get Involved
#4
Thanks a lot for your reply,
so the medical devcie will be assigned a udi-di and for the packaging of the device is the ud-di the same or do i have to assign a different one for the packaging knowing that it will be a package of 1. thanks
 

xcanals_tecno-med.es

Involved In Discussions
#5
In short, yes. only one device + packaging with one UDI-DI , same in both

but note that the medical devices is not only the "device" itself you must consider the total product = device + label + ifu + packaging
for example if you have 2 variants :

1. "device" + IFU English
2. "device" + IFU Spanish

they must have different UDI-DI
Think always like a supermarket cashier: different (final) product --> different barcode (UDI)

Xavier Canals
 
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