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CE Mark - Placing the CE mark on medical device labels

#1
Hi,

I have a question regarding placing the CE mark on medical device labels:

The device is approved in the EU, US, and other geographies, but with a slightly different Indication for Use for several of those markets. Hence, the labeling cannot bear the CE mark on all labeling unless it is aligned with the approved indication for use in that particular country.

Not wanting to maintain separate labels, and part numbers, for each market, it was proposed to create a single generic label without the CE mark, but with an empty space that Manufacturing would apply the CE for those appropriate markets where the device is intended to be shipped.

Is it possible to use such a generic label with no CE mark on it but with an empty space for a standalone CE mark label/sticker where required (under MDR regulation)?

Thank you very much in advance,
Yael
 

kreid

Involved In Discussions
#2
I would say so, I am aware of distributors, in various territories, adding labels to supplement manufacturer labels.
 
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