Authorized Representative services for Category I, II, and III protective equipment under PPE Regulation 2016/425, ensuring EU market compliance.
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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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GUANGZHOU INSPECTION TESTING AND CERTIFICATION GROUP CO.,LTD. · China
Testing and certification services for medical protective equipment including protective clothing, gloves, masks, and face shields. Evaluation covers performance, safety, and compliance with relevant medical and occupational safety standards.
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.
Metecon GmbH · Germany
Regulatory representation services for medical devices and IVDs under MDR, IVDR, and related frameworks. EC-REP, CH-REP, and PRRC designation support enables market access and compliance across EU and international jurisdictions. Expert guidance on regulatory strategy, documentation, and post-market obligations.
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