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Veterinary Medical Devices - Glucose monitoring system

M

missjenny

#1
We are planning to market veterinary glucose monitoring system composed of a meter, test strips, and control solutions in the EU. Since veterinary medical devices are not medical devices in the EU, I was thinking of using the EMC Directive 2014/30/EU to declare conformity for the meter. What route should I take for the test strips (reagent) and control solutions? Could they be included in the self-declaration via EMC Directive? Also, from what I have read in the EMC Directive, even though we are not situated in Europe, we are not required to have an EC Representative. Am I understanding this correctly?
 
Elsmar Forum Sponsor
M

missjenny

#3
Thank you Marc for your kind reply.

Unfortunately, there does not seem to be a clear regulation for veterinary products.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Veterinary products are such a niche area that I understand that it is difficult to get information on. I wanted to try to help, which is why I posted, but I do not know of a good source of information or discussion group related to veterinary topics.

Sorry you did not find help here or in the Linkedin group.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
We are planning to market veterinary glucose monitoring system composed of a meter, test strips, and control solutions in the EU. Since veterinary medical devices are not medical devices in the EU, I was thinking of using the EMC Directive 2014/30/EU to declare conformity for the meter. What route should I take for the test strips (reagent) and control solutions? Could they be included in the self-declaration via EMC Directive? Also, from what I have read in the EMC Directive, even though we are not situated in Europe, we are not required to have an EC Representative. Am I understanding this correctly?
Hi,

I've sent you a private message regarding that query, shortly after you posted. Have you seen it?

Cheers,
Ronen.
 
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