UK Responsible Person (UKRP)
Access the Great Britain medical device market
Following Brexit, manufacturers located outside the UK must appoint a UK Responsible Person to place medical devices and IVDs on the Great Britain market.
What is a UK Responsible Person (UKRP) and who needs one?
A UKRP is a natural or legal person established in the United Kingdom who is appointed by a manufacturer based outside the UK to act on their behalf. The UKRP assumes responsibility for specific tasks under the UK MDR 2002 and communicates with the Medicines and Healthcare products Regulatory Agency (MHRA).
Following Brexit, manufacturers located outside the United Kingdom — including those in the EU — must appoint a UK Responsible Person (UKRP) to place medical devices and IVDs on the Great Britain market. This requirement is defined under the UK Medical Devices Regulations 2002 (as amended).
Qarad UK Ltd., part of the QbD Group, is an experienced and independent UKRP based in London. We are a member of the UK Responsible Person Association (UKRPA), committed to professional conduct and regulatory excellence.
Who needs a UKRP?
• Medical device or IVD manufacturers based outside the UK
• EU-based companies selling into Great Britain
• Global manufacturers entering the UK post-Brexit
Why partner with QbD Group?
Qarad UK Ltd., part of the QbD Group, is your trusted partner for UK market access.
Proven expertise
Over 20 years of experience in medical device and IVD representation in the EU, and now Switzerland and the UK.
Regulatory credibility
UKRPA member promoting professional conduct and competence.
Independent representation
We help you avoid conflicts of interest that may arise when appointing a UK importer.
Comprehensive support
Guidance on UK-specific requirements, handling of MHRA interactions, and regulatory advice throughout the product lifecycle.
Dual market alignment
We support both EU and UK market access strategies through one trusted partner.
How can we help you as a UKRP?
Qarad UK offers a dedicated team of international regulatory professionals with strong local knowledge. We ensure efficient registration, accurate documentation handling, and smooth communication with the MHRA. As your UKRP, we will:
Register with the MHRA
Register with the MHRA and provide required information, including proof of appointment and manufacturer details.
Verify documentation
Verify the manufacturer has drawn up the Declaration of Conformity and technical documentation. Maintain copies available for inspection.
Respond to MHRA requests
Respond to MHRA requests by providing necessary information or documentation. Forward requests to the manufacturer and communicate responses.
Safety & corrective actions
Cooperate with the MHRA on preventive or corrective safety actions. Communicate complaints or incident reports from users or professionals.
Our 3-step onboarding process
Getting started with Qarad UK as your UKRP is straightforward:
1. Mandate & setup
We formalize the UKRP agreement and gather documentation.
2. Compliance check
We assess documentation readiness for MHRA.
3. Official representation
We register your product and maintain UKRP responsibilities.
UKRP Frequently Asked Questions
Yes. The UKRP role was introduced post-Brexit and is functionally similar to the EU Authorised Representative under MDR/IVDR.
Technical documentation, Declaration of Conformity, UK labelling, manufacturer contact info, and PMS documentation.
Absolutely. We have dedicated teams for both UKRP and EU-REP services, making your global strategy seamless.
Authorized Representative Services for the EU and Switzerland
Why QbD Group
Your trusted partner
Part of the QbD Group, Qarad UK Ltd. is your trusted partner for UK market access.
Proven expertise: Over 20 years of experience in medical device and IVD representation.
Regulatory credibility: UKRPA member promoting professional conduct and competence.
Independent representation: avoid conflicts of interest that may arise with UK importers.
Comprehensive support: UK-specific requirements, MHRA interactions, and full lifecycle advice.
Dual market alignment: EU and UK market access strategies through one trusted partner.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.