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Selling medical devices or IVDs in the UK? You need a UK Responsible Person (UKRP). QbD Group ensures your compliance with UK MDR 2002 (as amended), helping non-UK manufacturers bring their products to the UK market successfully. Market your product in the UK with full confidence.
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).
QbD 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.
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QbD 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.
Our Role as Your UK Responsible Person As your UKRP, we will:
Register your devices with the MHRA and maintain accurate records
Review and ensure your technical documentation is complete and compliant with UK standards
Maintain a secure copy of your technical file, available for MHRA review
Act as your UK point of contact for MHRA communication
Respond to any MHRA request, including data, documentation, or corrective actions
Ensure your device labelling includes required UKRP information
Proven expertise: Over 20 years of experience in medical device and IVD representation in the EU, Switzerland, and now 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
Looking for a reliable UK Responsible Person? QbD Group is ready to support your successful market entry into Great Britain.
Do you want to appoint an Authorised Representative to sell your products in the EU or Switzerland?
Find out more about our European and UK representative services:
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