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Additional requirements for selling Class I Medical Device in Poland

B

bikeshox

#1
Hi guys, Quick question. Are there any additional requirements for selling Medical devices in Poland?

We have a customer in Poland who we're producing a private label for. They claim that we need our name and address on the product.

My understanding, is since they are the manufacturer by definition, our Name & address does not belong on the label.
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Do they agree that they are a private label manufacturer, and understand what they're agreeing to?

Is the CE Mark on the label yours or theirs?

Perhaps instead their understanding is that they're just a distributor, and while their name appears as a sort of branding, your name must be present because after all you're the responsible manufacturer.

I don't see how this disagreement can exist unless there's either a communications disconnect or a misunderstanding of the rules.
 
B

bikeshox

#3
I don't see how this disagreement can exist unless there's either a communications disconnect or a misunderstanding of the rules.
Oh where do I begin?... Just making sure, I wasn't the crazy one.

Our management/sales seems to assume that whom ever we do business with, is competent in Private Labeling without getting signed agreements...
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Wherever you deal with people whose first language is not identical to yours, beware.

(The above also applies to English and American, etc.)
 
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