What is so important about having an European Authorized Representative (EC REP)?
The EC REP performs certain duties under the European Medical Devices Regulations and acts as a legal interface between the Medical Device manufacturer and the EU Authorities. Appointing MDSS as your EC REP will effectively put your company on the forefront of European Regulatory Requirements. We meet the criteria for CE marking and, more importantly, MDSS has sufficient experience in Regulatory Affairs to provide this demanding and highly `responsible´ service!
When to designate the Authorized Representative?
We say: from the start! Ensure a smooth and efficient process!