European Representative
According to Medical Device Directive 93/42/EEC every manufacturer of a Medical Device who is based in a non-member state of the European Economic Area (EEA) and intends to import Medical Devices into the EEA,is required to have an Authorized Representative within the Community. The Authorized Representative is responsible to register the establishment and its products at the competent Authority. Further the Authorized Representative is seen as the Official Correspondent of the manufacturer by the Competent Authority.