IVD: Overlabeling in the EU?

[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]

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.

 

[dgrainger]

UK guidance on Virtual Manufacturing is available here:
Medical devices: Virtual Manufacturing replaces Own Brand Labelling - GOV.UK

 

[pkost]

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

 

[EthanLoh]

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

What is the content change? Expiry date?