M
missjenny
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?