What is an EC Rep?
A European Authorised Representative (EC REP) is a liaison between non-EU medical device manufacturers and national competent authorities and notified bodies in the EU. An EC Rep is an EU-established point of contact that ensures the compliance of non-EU medical devices with European directives.
The appointment of an EC REP is a requirement of the European Medical Device Regulations and In Vitro Diagnostic Medical Device Regulation for non-European manufacturers wishing to sell medical devices and in vitro diagnostics on the European market.
