European legislation - namely Medical Device Directive 93/42/EEC and its amendment EU Directive 2007/47/EC - requires medical device manufacturers located outside the European Community to select a single European Authorized Representative.

This Authorized Representative serves as a legal entity to represent the manufacturer within the European Union and to establish contact to EU Competent Authorities.

The mission of the  European Authorized Representative (EAR) is to take care that all medical products placed on EC market are in full compliance with EU legislation. Thus the  EAR takes all necessary steps like collecting and storing data and documentation needed and performing registration on behalf of the manufacturer if necessary.

Thus appointing the EU Authorized Representative is (beside getting for all but Class I products the CE mark) the primary task which has to be addressed before your medical products could be placed legally on EC market.

The EAR is also the primary contact with EU Authorities in all questions regarding your medical products. Therefore it is a legal requirement that the Authorized RepresentativeĀ“s contact info is placed on your medical products.