UK Responsible Person Services for Medical Devices
Our UK Responsible Person (UKRP) services support non-UK medical device manufacturers in complying with UK medical device regulations and accessing the Great Britain market. Patient Guard acts as your designated UK Responsible Person, ensuring full regulatory compliance and market readiness.
UK Responsible Person Services
Under the UK Medical Devices Regulations 2002 (UK MDR 2002, as amended), manufacturers based outside the United Kingdom must appoint a UK Responsible Person to place medical devices on the Great Britain market.
The UK Responsible Person acts as the official point of contact between the manufacturer and the MHRA, ensuring compliance with UK regulatory requirements and supporting ongoing post-market obligations.
Failure to appoint a compliant UKRP prevents legal market access within Great Britain and may result in regulatory enforcement action.
Patient Guard provides professional UK Responsible Person services tailored to medical device and IVD manufacturers. We ensure your technical documentation, labelling, and regulatory obligations meet UKCA requirements and MHRA expectations.
Our team supports you throughout the full device lifecycle—from initial registration through to post-market surveillance and vigilance support.
Why Choose Patient Guard as Your UK Responsible Person?
BSI-Certified Quality Oversight
Our legal UKRP services are executed under our own BSI-certified ISO 13485 Quality Management System, assuring you that your regulatory compliance is managed to the highest standard.
Continuous Regulatory Availability
Our regulatory team is permanently at your disposal to act as your direct, legal point of contact within Great Britain, ensuring continuous compliance and instant response readiness for the MHRA.
Established MHRA Track Record
Operating since 2017 with deep technical knowledge of the UK market, we navigate the MHRA DORS portal daily, eliminating administrative friction and accelerating your time-to-market.
As your UKRP, we take on joint legal liability for your devices. Unlike ‘mailbox’ representatives, we perform a robust initial due diligence audit of your Technical File to ensure your certification remains stable and your liability is covered by our comprehensive professional indemnity insurance
What Our UK Responsible Person Service Includes
MHRA Device Registration
We handle the end-to-end administration of listing your medical devices and IVDs within the MHRA portal, ensuring all product data is correct and compliant with UK MDR 2002.
Technical Documentation Verification
We systematically review your CE/UKCA technical documentation and Declarations of Conformity to confirm your files strictly satisfy the required regulatory pathways before market entry.
Direct Competent Authority Liaison
We act as your officially designated UK representative, field all technical inquiries from the MHRA, and seamlessly coordinate the provision of device samples or documentation when requested.
Vigilance & Incident Support
We work directly alongside your internal teams to report, manage, and track any adverse post-market events, safeguarding your UK compliance and corporate reputation.
Importers & Distributors Alignment
We maintain strict legal transparency by keeping all required UKRP address lines correctly configured across your device labeling, packaging, instructions for use, and supply channels.
Who Requires a UK Responsible Person?
- Non-UK medical device manufacturers
- Companies placing devices on the Great Britain market
- Organisations seeking UKCA marking
- Distributors requiring compliant UK representation
UK Responsible Person Requirements
Under UK MDR 2002, manufacturers outside Great Britain must:
- Appoint a UK Responsible Person
- Register devices with the MHRA
- Maintain compliant technical documentation
- Ensure correct UKRP labelling
- Support vigilance and post-market activities
A compliant UKRP is essential for legal access to the Great Britain market.
Our Process
Step 1 – Initial Consultation & Assessment
We assess your devices, intended market, and UK regulatory requirements
Step 2 – Documentation Review & Registration
We review technical documentation and support MHRA registration and compliance setup
Step 3 – UKRP Appointment & Ongoing Support
We formally act as your UK Responsible Person and provide ongoing regulatory and vigilance support
Industries We Support
We support UKRP services across:
- Medical device manufacturers
- Digital health and SaMD companies
- Start-ups entering the UK market
- Global healthcare technology companies
Cost of Service
UK Responsible Person Services for Medical Devices
Per Year
Ensure your smooth entry into the UK Medical Device market with an UKRP you can trust
Features
- UKCA/CE Marking Compliance Support
- Official UK Responsible Person
- Fast Onboarding
- Ongoing Regulatory Support
- Price includes unlimited number devices
Time Lines
Week 1 – Initial Review & Agreement
Assess your devices, confirm UK MDR requirements, and establish the UK Responsible Person letter of designation
Week 2 – Documentation Verification & Setup
Review technical documentation, Declaration of Conformity, and ensure labelling compliance
Week 3 – Appointment & Ongoing Compliance
Formal UKRP appointment, MHA registration, and initiation of ongoing regulatory and vigilance support
Frequently Asked Questions (FAQs)
What is a UK Responsible Person?
A UK Responsible Person is a legal entity established in the UK that acts on behalf of a non-UK manufacturer to ensure compliance with UK medical device regulations.
Is a UKRP mandatory?
Yes, all manufacturers located outside Great Britain must appoint a UKRP to place medical devices on the GB market.
Does Northern Ireland require a UKRP?
Northern Ireland follows EU MDR/IVDR requirements and may require an EU Authorised Representative instead, depending on the route to market.
What are the responsibilities of a UKRP?
Responsibilities include documentation verification, MHRA registration support, regulatory liaison, and vigilance support.
How long does UKRP onboarding take?
Onboarding can typically be completed within 1–2 weeks depending on documentation readiness.
Related Services
Click on the links below to discover more:
Recent Blog Posts
The AI Act Omnibus Explained: What the 2026 EU Rules Mean for Medical Device and IVD Manufacturers
Discover how the EU AI Act Omnibus affects AI medical devices and IVD manufacturers. Learn about the No Duplication principle, transparency rules, key 2026 and 2028 deadlines, and how MDR and IVDR compliance are converging with AI regulation.
Post-Deadline Reality Check: I’ve Submitted My IVDR Class C – Now What?
Submitted your IVDR Class C application? Learn what happens next, common causes of delays, review timelines, and why the September 2026 contract deadline is critical for maintaining EU market access.
The MHRA 2026 Regulatory Roadmap Explained
Learn how the MHRA 2026 Regulations will impact UKCA compliance, IVD classifications, AI medical devices, IRP pathways, and post-market surveillance.
Medical Device Regulatory Consulting Services Explained
Explore medical device regulatory consulting services for ISO, FDA, EU, and more. Build compliant systems, pass audits, and scale globally with expert support.
Patient Guard’s QMS Achieves ISO 13485 Certification
A milestone that strengthens our commitment to quality
Regulatory and quality consulting is one thing. Building, implementing, and passing audits on your own Quality Management System is another.
UDI Medical Devices: Types Explained (EU MDR Guide)
UDI medical devices are not just a labelling requirement. They are the backbone of traceability under EU MDR.
