All products offered by Consol are classified as Medical Devices and as such are regulated by the EU Medical Device Directive

Intertek Semko Certification AB is our current Notified Body, accredited by the Swedish Board for Accreditation and Conformity Assessment, who in turn collaborates with the Swedish Medical Products Agency. Our certification includes ISO 13485, and applies to development, manufacturing and sales of contact lens care products and eye comfort solutions. Consol is EC certified for Medical Devices.