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.
Author Ferry Vermeulen is the Co-Founder of 24hour-AR, a company dedicated to providing authorised representative services as well as CE marking services. With a background in industrial design engineering, Ferry specialises in facilitating swift compliance with EU regulations, enabling manufacturers to enter markets seamlessly.
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