IVD Veterinary Testing - European Market Regulations

[belemsanchez]

Please, I'd liKe to start a new thread about this kind of products: IVD test for Veterinary Diagnostics, specifically IVD test for Companion animals.

All companies producing and distributing human in-vitro-diagnostics in the EU have to comply with the regulations according to the Directive 98/79/EC.
But I think that a similar regulatory guidelines for veterinary diagnostic kits are not available at this time within the EU, correct?

They don't fall into the Directive 2001/82/EC, to veterinary medicinal product.

So, I think that in the European Member States different legal requirements are in place. Example, in Spain it's requested a licence to manufacturer, import and sell. Anybody knows if in others European Member States is the same?

Thanks a lot

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!

Stijloor.

 

[Marc]

Another quick "Bump". My Thanks in advance to anyone who can help with this one.

 

[belemsanchez]

Thanks I'm very grateful for the support, but I seem that this item is not very popular, but it's a new field with many bussiness, I'm talking about animal testing market for production animals, livestock as well as companion animals, pets.

 

[Marc]

One last quick "Bump". My Thanks in advance to anyone who might be able to help with this one.

 

[cemark]

I'm looking for similar information. A quick google search brought up the attached doc.

Unfortunately it doesn't answer the question about requirements for individual member states.

 

[missjenny]

I am in a similar situation as well. Did you ever find the solution that you were looking for?