The first step to success in the European Union Marketplace is compliance with EU regulation. Essential to EU compliance is the correct classification of your devices. An excellent demonstration of the importance of proper classification deals with the MDD 93/42/EEC. The MDD 93/42/EEC requires Medical Device Manufacturers to classify their devices before placing their products in the European Union. This classification is extremely important and will determine the compliance route for CE marking and market placement.
Once a medical device has been properly classified a European Authorized Representative will be appointed (for Non-EU manufacturers) and a European Notified Body will be able to proceed with the required conformity tests applicable to the manufacturer’s device.
It is important to note that IT IS THE SOLE RESPONSIBILITY OF THE MANUFACTURER TO CLASSIFY THEIR DEVICES AS PER EUROPEAN REGULATION!
Obelis European Authorized Representative Center (OEARC) can provide you with such service: Confirmation of Classification. Obelis will contact the competent authorities of an EU Member State in the manufacturer’s behalf to obtain a confirmation of the device classification.
Obelis Device Classification Services will:
• Simplify your transition into the EU Marketplace
• Put to rest class disputes with third parties (European Notified Bodies, Potential Clients, etc.)
• Clarify “borderline” devices
• Provide a European Recognized classification confirmation for your device