A Step-by-Step Guide to UKRP

Key Takeaways

MDR/IVDR

The MDR and IVDR will not be applicable in Great Britain as the MHRA decided not to implement the MDR as per the EU MDR transition timelines.

NI Trader

The Northern Ireland traders can place their CE and CE UKNI marked devices on the Great Britain market after 30th June 2023. Also, the Northern Ireland manufacturer who has already registered his device with the MHRA for NI, it can continue to be placed on the GB market and does not have to undergo any separate registration process for GB.

MMD bill

UK MMD Bill (Medicines and Medical Devices Bill 2019- 21) has introduced a standalone regulatory framework for Great Britain. The main aim of this bill is to meet the gap after the UK left the EU and covers human medicines, clinical trials of human medicines, veterinary medicines and medical devices.

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 inestablishing 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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