MedNet EC-REP provides European Authorized Representative and regulatory representation services for non-European manufacturers seeking market access to Europe. Founded in 1990 by David Thaler to address regulatory access barriers facing international manufacturers, the company introduced regulatory services in 1994 and now serves more than 700 manufacturers across the medical-device, in-vitro diagnostics, cosmetics, personal protective equipment and consumer-product sectors.
Its services cover the full regulatory lifecycle: European Authorized Representation through MedNet EC-REP GmbH (established in 2019), UK Responsible Person services for the Great Britain market, Swiss Authorized Representative services, regulatory importer and legal representation, product registration for medical devices and other regulated products, and post-market vigilance and market-surveillance support. Technical work spans medical-device regulatory affairs, regulatory compliance, product registration and quality management under ISO 13485, with an ISO 13485-certified quality management system in place.
The company operates across Europe and Asia, with a China office opened in 2014, and describes an emphasis on scientific expertise, direct client contact and rapid response times. Team size and funding are not disclosed.
