What is so important about having an Authorized Representative?
Non-European Medical Device manufacturers exporting to Europe must designate an Authorized Representative
, that is established in the European Community, to fulfill one aspect of the requirements for CE marking.
The Authorized Representative performs certain duties under the European Medical Devices Directives
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!
MDSS forges powerful alliances and provides timely, comprehensive solutions for our clients´ protection, benefit and corporate endurance. We strive to provide the best representation in the ever changing maze of European Regulations.
MDSS, your products´ first class address, will be synonymous with quality products and compliance with the European Medical Device requirements. Because each client is unique and different, MDSS provides a customized solution for each one.
MDSS serves both the Medical Device and the In Vitro Diagnostic Medical Device industries worldwide. Our clients are successful in their local marketplace and have expanded their expertise into the European arena with MDSS as their Authorized Representative and Regulatory Partner.
Medical Device Directives Division [MDD]
Please click here to learn more about our MDD Division
In-Vitro Directives Division [IVDD]
Please click here to learn more about our IVDD Division
Active Implantable Medical Device Directive Division [AIMDD]
Please click here to learn more about our AIMDD Division