How Freyr can help

Freyr offers multiple and flexible service models to choose, based on the manufacturer's operating model.


Freyr expertise

Freyr is a leading global Regulatory solutions and services provider specialized in Medical Devices Regulatory support. With a registered office in Berkshire, Freyr is poised as the go-to UK Responsible Person Services provider with end-to-end Regulatory support for registering and marketing your Medical and In-Vitro Devices in the UK.

Freyr Advantages

  • Dedicated single point of client service contact
  • Highly qualified professionals as UKRP delivering compliance-oriented comprehensive services
  • Tailor-made as per client requirements
  • Saving valuable time for businesses considering quick set-up service
  • Offering industry standard economic solutions for healthcare businesses

UK Distributor/Importer

The UK distributor and UK importer can act as a UKRP for a foreign medical device manufacturer, provided they comply with UK MHRA pre-requisites and have the required Quality Management System in place. Freyr can support in establishing the procedures or remediate existing procedures to comply with the MHRA regulations.

Download Freyr Free UKRP Guide

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Resources

  • When should a medical device manufacturer appoint a UKRP and what is the associated legal basis?

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  • What are the varied roles of a UK Responsible Person?

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  • Medical Devices in the UK & UKRP: Latest Industry Updates

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