A Step-by-Step Guide to UKRP

MHRA Mandate

MHRA has made it mandatory to appoint a UKRP if the manufacturer of the medical device is not based in the UK. The UK Responsible person services include registering the medical devices with MHRA on behalf of the manufacturer, ensuring conformity to be available for inspection, responding to any queries from MHRA and carrying out Post Marketing Surveillance (PMS) activities.

Role of UKRP

The appointed United Kingdom Representative should register device products with the MHRA.

Eligibility for being a UKRP

Any third-party entity or an importer or distributor can act as a UK Responsible Person on a foreign manufacturer’s behalf.

Timeline

 

The timeline for appointing a UKRP is in line with the timeline for getting the device registered with MHRA i.e., 4 months, 8 months and 12 months for different classes of devices.

 

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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