A Step-by-Step Guide to UKRP

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 distributors and importers 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.

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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  • What are the routes to market Medical Devices in Britain and Norther Ireland (NI)? What are the UKRP solutioning models?

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