CE Mark is the European Community requirement for selling devices within Europe. This means that without the CE Mark you cannot sell your medical device within the European Community. The CE Mark represents compliance with a specific device directive which can be achieved through self assessment or a certification body depending upon the device classification. For medical devices, the European Community requires compliance with the three special directives (Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD) and the Active Implantable Medical Device Directive (AIMDD)) in order to put the CE Mark on your device.
mdi Consultants can guide you to determine what is the best way to achieve a CE Mark and assist you through the entire process of securing it. We have helped over 100 companies successfully achieve the CE Mark. Our customer testimonials will provide you a glimpse of the experience of working with mdi on CE Marking.
Our CE Mark services include:
Technical File Preparation
Selection of Certifying Body
Responsible Person Assistance
In addition, the successful application of a CE Mark may require compliance with the ISO set of global quality standards. mdi can also help you to achieve ISO certification.