Regulatory representation and compliance support for clinical investigations of medical devices under MDR 2017/745 and IVDR 2017/746. Provides EU-REP authorization, importer services, and regulatory guidance for Class I-III devices and IVD products across EU, UK, and Switzerland markets.
Manufactured by
MedNet EC-REP GmbH
Münster, Germany
With many years of experience and a highly qualified team, MedNet EC-REP offers all services for the pan-European marketing authorization of your products: the European Authorized Representative (EC-REP), the UK Responsible Person (UK RP) and the Swiss Authorized Representative (CH-REP). We specialize in medical devices, in vitro diagnostics (IVD), personal protective equipment (PPE), clinical investigations and performance studies, and application for certificates of free sale (FSC).
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