Medical Device Manufacturers that do not have a physical location in Europe must appoint a EU Authorised Representative located within Europe. The Authorised Representative is mandatory for EU MDR & IVDR Medical Device CE Marking. EC Rep is applicable for all classes of medical devices.
EU Authorised Representative Name and Contact information must be visible on device information panels. Representative must be chosen based on their experienced and experienced handling of the regulations of Medical Devices and related regulatory requirements.