European Authorized Representative

Non-European Medical device manufacturers wanting to sell their products within the European Union must have an Authorized Representative with a physical address in the EU.  There are many policies and regulations associated with selling medical devices in the EU, and these are continually being updated and changed,  your Authorized Representative must be aware of policy adjustments and regulatory changes that may occur.  You cannot simply have a post office box located in the European Union, you are obliged to have a representative that is a registered business with a legitimate EU address.  Your European Authorized Representative has the responsibility of observing the manufacturer’s compliance with the conformity assessment procedure set out in the European Directive that applies to your specific product(s).  They are also there for vigilant intervention and to handle and file any and all complaints and claims in regard to your product, and must therefore be a specialized and professional company.

Qserve maintains a close relationship with Obelis SA, a European Authorized Representative.  Obelis is located in Brussels, Belgium, in the heart of the European Union.  Obelis is the largest professional Authorized Representative service in Europe, offering the complete range of European Authorized Representative services.  This relationship between Qserve and Obelis provides for full Authorized Representative services from a trusted and high-quality service provider. 

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