Regulatory representation and legal support for conducting and documenting performance studies on in vitro diagnostic devices under IVDR 2017/746. Ensures compliance with EU/UK requirements for IVD clinical evidence generation across all risk classes.
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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MDSS USA LLC · United States
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.
MDSS USA LLC · United States
European Authorized Representative and regulatory compliance service for medical devices and IVDs. Provides in-country representation across EU, UK, Switzerland, USA, and Australia to ensure manufacturers meet MDR, IVDR, AI Act, and GDPR requirements.
BIOMEX GmbH · Germany
Contract research organization service specializing in in vitro diagnostic test validation. Services include ethics approvals, study design, sample provision, laboratory analysis, and regulatory compliance documentation for EU IVDR, TGA, and WHO standards.
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