EU-REP regulatory representation and compliance service for medical devices, IVDs, cosmetics, and PPE across EU, UK, and Switzerland markets. Supports all device risk classes under MDR 2017/745, IVDR 2017/746, and GPSR regulations. ISO 13485 certified with expertise in pre-market documentation, post...
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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Regulatory consulting and in-country representation services for medical devices and IVDs across EU, UK, Switzerland, USA, and Australia. Enables non-domestic manufacturers to achieve market compliance and maintain regulatory standing in multiple jurisdictions through appointment as Authorized Representative or equivalent legal entity.
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