European Authorized Representative (EC REP)
European Authorized Representative for Medical Devices (MDR (EU) 2017/745) and In Vitro Diagnostic Devices (IVDR (EU) 2017/746).
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), to fulfill one aspect of the requirements for CE marking.