mdi Consultants
A CE Mark is the European Community requirement for selling medical devices within Europe. Without a CE Mark, you cannot sell your medical device product within the European Community. The CE Mark represents compliance with a specific EU Medical device directive, which is achieved through self-assessment or via an EU certification body, depending upon the device’s classification. To put the CE Mark on your medical devices, the European Community requires compliance with the three special directives: the Medical Device Regulation (MDR); the In-Vitro Diagnostic Regulation (IVDR); and, the Active Implantable Medical Device Directive (AIMDD).
mdi Consultants’ CE Mark Service can guide you to determine the best way to achieve a CE Mark, and assist you through the entire process of securing it. We have consulted and worked with over 100 companies to successfully achieve the CE Mark. Our clients’ testimonials will provide you a glimpse of the experience of working with mdi on CE Marking.
