The appointment of an European Authorized Representative (EC REP) for the Member States of the EEA is required in the European Medical Device Regulations (Medical Device Regulation (MDR (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746).
An EC REP is the main contact for the European Commission and the National Competent Authorities. Appointing MDSS as your EC REP will effectively put your company on the forefront of European Regulatory Requirements.
What is so important about having an European Authorized Representative (EC REP)?
Non-European Medical Device manufacturers exporting to Europe must designate an EC REP, that is established in the European Community, to fulfill one aspect of the requirements for CE marking.
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. This is why MDSS was founded. 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!