Medical Device Manufacturers that do not have a physical location in Europe must appoint a European Authorized Representative (EU Representative) who is located within Europe.
EU Rep / EC Representative is mandatory for EU MDR & IVDR Medical Device CE Marking. EU Representative is applicable for all class of medical device. EU Representative name and contact information must be visible on device information panels
An Authorized European Representative must be chosen based on their experienced and experienced handling in regulations of Medical Devices and related regulatory requirements.