IVD: Overlabeling in the EU?

F

fondantcookie

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
 
GStough

GStough

Leader
Super Moderator
fondantcookie said:
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
Click to expand...

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.
 
P

pkost

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

EthanLoh

There is no restriction defined in the IVDD. However it is undesirable. :nope:

What is the content change? Expiry date?
 
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