Regulatory representation service enabling medical device manufacturers to market products in the UK under the Medical Devices Regulations. The service manages post-market surveillance, technical documentation, and compliance obligations for Class I through Class III devices, allowing manufacturers ...
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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Obelis Group S.A. · Belgium
UK Responsible Person designation and regulatory compliance service for medical devices and in vitro diagnostics entering the UK market. Ensures manufacturers meet UK MDR and IVDR post-Brexit requirements, including technical file preparation, quality management oversight, and regulatory submissions.
MDSS USA LLC · United States
UK Responsible Person (UKRP) representation service for medical devices and IVDs seeking market authorization in the United Kingdom. Ensures regulatory compliance with UK MDR requirements and facilitates in-country representation for non-UK established manufacturers.
EUCEREP B.V. · Netherlands
UK Responsible Person regulatory representation service enabling non-EU medical device manufacturers to achieve compliant market access in the UK. Encompasses MHRA registration, technical documentation support, Quality Management System establishment, and ongoing regulatory compliance guidance.
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