EC REP: European Authorized Representative.
Due to the increasingly common presence of imported medical devices in the European Union, the figure of the Authorized Representative (EC REP, European Authorized Representative) is becoming more common. This figure must guarantee compliance with current regulations on medical devices for medical devices manufactured outside the European Union. Regulation 2017/745 of medical devices establishes the obligation for all manufacturers of medical devices established outside the European Union to have a permanent authorized representative who serves as an interlocutor for the European health authorities and has a documentary file with technical information. of medical devices (Technical file among others). The authorized representative must be a natural or legal person based in an EU member state and appear on the labels of Medical Device CE Marking for sale in the EU. The appointment of this EC REP must be in writing along with its acceptance and in the case of class I products, this ap