Authorized Representative Facility

European Authorized Representative Service

Vertical Registrar Inc.’s EU Authorized Representative Service goes beyond the obligations of European Medical Device Directives and associated EU guidelines, to provide professional advice. Non-food products are subject to numerous rules and regulations within the European Union (EU), compliance with which must be ensured by the manufacturer and/or importer. An authorized representative as contemplated by the Product Safety Act – also known as EU-REP – established in the European Economic Area can assist manufacturers and importers in fulfilling certain obligations. In this case, the European Authorized Representative acts as a link between the manufacturer and the market surveillance authorities and keeps extensive information available. In the process, the authorized representative is required to perform at least the following tasks:

• keeping the EC declaration of conformity and the technical documents at the disposal of national surveillance authorities for a period of 10 years after the product has been placed on the market,
• handing out all information and records necessary to demonstrate the conformity of a product to the competent authorities (upon reasoned request),
• cooperating with the competent national authorities on any measures needed to eliminate the risks arising from the products in question.