IVD: Overlabeling in the EU?

fondantcookie

Starting to get Involved
#1
Hi all,

Does anyone know if there are any countries in the EU that do not accept shipments of IVDs that have been overlabelled?

We are currently re-working a product which will now contain an over-label and I am concerned that some EU countries will not accept this...

Could anyone point me in the right direction?

Thanks in advance
 
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GStough

Staff member
Super Moderator
#2
Hi all,

Does anyone know if there are any countries in the EU that do not accept shipments of IVDs that have been overlabelled?

We are currently re-working a product which will now contain an over-label and I am concerned that some EU countries will not accept this...

Could anyone point me in the right direction?

Thanks in advance
Have you read the IVD Directive to see if over-labeling is allowed in the EU? I'm not certain that this is an acceptable practice in the EU, although a quick search through the IVDD did not reveal any specific requirements or restrictions on over-labeling.

Perhaps others may be more familiar with the IVDD and can offer better assistance.
 

pkost

Trusted Information Resource
#4
Can you be specific by what you mean by overlabel? What information do you intend to overlabel? what will change?
 
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