European Authorized Representative (EC REP)

The European Authorized Representative (EC REP) is a person or a legal entity who by designation of a manufacturer acts on their behalf. Your Authorized Representative is the main contact for the National Competent Authorities and performs certain duties under the European Medical Devices Regulations. The European Authorized Representative acts as the legal interface between you, the Manufacturer, and the EU Authorities. An Authorized Representative may be addressed by authorities and competent bodies, instead of the manufacturer themselves, with regards to the requirements of the Medical Device Regulations.

 

Appointing MDSS as your EC REP will set your company on the forefront of European Regulatory Requirements. We meet the full EU criteria for CE marking and, most importantly, MDSS has long-term experience in Regulatory Affairs necessary to provide this demanding and `highly responsible´ Authorized Representative service!