EUROPEAN AUTHORIZED REPRESENTATIVE (EAR) & US FDA Agent

FOR MEDICAL DEVICES

According to the European Medical Device Directive and Medical Device Regulation, a European Authorized Representative has to be appointed by a foreign (European Community ) manufacturer of medical devices, in-vitro diagnostics.

A European Authorized Representative (EC Representative, EC Rep) acts as the legal entity of manufacturers outside of the European Community and fulfills the manufacturer’s obligations according to the relevant European directives.

On behalf of the manufacturer, the European Authorized Representative may deal with the European regulatory authorities regarding Declarations of Conformity, European labeling and language requirements, incident reporting, notification performance for clinical investigations, Free Sales Certificates or Certificates of Marketability as well as Certificates of product registration.

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