The information provided on this page is not intended as legal advice. Please contact and enter into commercial arrangements with ZP before implementing this strategy.
Abaxis taught us that when facing obstacles in introducing a medical diagnostic to the market, it can be beneficial to pivot and explore the veterinary space. One of the strategies you can consider with ZP is introducing diagnostic products in the veterinary space before the medical space.
In the veterinary market, manufacturers can place diagnostic products on the European market as long as they adequately document their product assessment. Products that are pressurized or have electronics that could generate or be affected by the electromagnetic environment may hinder CE self-assessment.
The SenseItAll (SIA) platform from ZP serves as an example of a platform that can serve as the foundation for a CE-marked product in the European veterinary space, as the only directive applicable is the Electromagnetic Compatibility (EMC) Directive 2014/30/EU.
