UK Responsible Person (UKRP) Services
Trusted by 250+ medical device & IVD manufacturers across 20 countries
✓ Full UKRP setup from contract to MHRA registration in just 2-4 weeks
✓ Fast, responsive support from experienced regulatory professionals
✓ Direct access to your dedicated regulatory contact (no generic inboxes)
✓ Transparent, flat-fee pricing with no hidden costs
New to UKRP requirements? Learn more about the process below ↓
Why You Need a UK Responsible Person
Following Brexit, medical device and IVD manufacturers without a UK registered office must appoint a UK Responsible Person (UKRP) to place devices on the Great Britain market (England, Scotland, and Wales). An EU Authorised Representative is no longer recognized in Great Britain.
The UKRP serves as your regulatory representative in the UK, managing MHRA device registration, maintaining technical documentation, and acting as your point of contact with the MHRA. Without a designated UKRP, you cannot legally market your medical devices in Great Britain.
Note: Northern Ireland continues to require an EU Authorised Representative under the Windsor Framework (which replaced the Northern Ireland Protocol in 2023).
What Your UK Responsible Person Does
As your UKRP, Casus handles all regulatory responsibilities required by the MHRA:
MHRA Registration & Compliance
- Register your company and medical devices with the MHRA
- Register and manage your UK importers
- Process registration updates
- Verify CE or UKCA marking compliance
Documentation & Technical Support
- Maintain copies of technical documentation and declarations of conformity
- Ensure conformity assessment procedures are properly completed
- Keep documentation available for MHRA inspection
Regulatory Liaison
- Serve as your official point of contact with the MHRA
- Coordinate responses to MHRA inquiries
- Support vigilance and post-market surveillance activities
- Help manage field safety corrective actions when needed
Questions?
Explore how we can assist with your market entry or provide a tailored quote. We would be happy to schedule a no-obligation call to discuss your needs.
Our UKRP Service Process
Complete service from contract to MHRA registration in 2-4 weeks.
- Contract & Onboarding (1-3 days): Sign your UKRP agreement and provide device technical documents. Our fast onboarding gets you started in days, not weeks.
- Documentation Review (3-5 business days): Casus reviews your technical documentation for completeness. Class I devices and Class A IVDs may take 2-3 weeks if manufacturers need to complete or update technical documentation to meet compliance requirements.
- MHRA Registration (2-3 business days): We submit your registration to the MHRA and handle all communication with the agency.
- Ongoing Support: Direct access to your dedicated regulatory team for renewals, updates, and MHRA inquiries.
Why Manufacturers Choose Casus
Fast, Responsive Service: Our client onboarding is one of the fastest in the industry, completed in days compared to the weeks (or months) quoted by other providers. High-quality project management means you can be confident about results and timelines.
Transparent, Fair Pricing: No hidden costs or surprise fees. We don’t increase your UKRP service fee when you add products later. You’ll receive straightforward, professional service with clear pricing from the start.
Experienced Regulatory Team: We’ve completed hundreds of UK device registrations and understand how to navigate MHRA requirements efficiently. You will have direct access to knowledgeable regulatory professionals; no intermediaries, junior employees, or ticket systems.
Proven Track Record: Trusted by 250+ medical device and IVD manufacturers across 20 countries for EU, UK, and Swiss regulatory representation services.
UKRP Requirements & FAQs
Common questions about UK Responsible Person requirements and our services:
Do I need a UK Responsible Person?
Appointing a UK Responsible Person is mandatory before placing medical devices or IVDs on the Great Britain (England, Scotland, Wales) market. Manufacturers placing devices without a designated UKRP and completed MHRA registration are out of compliance.
Does the UKRP need to be on device labeling?
It depends on your Marking:
UKCA Marked devices: UKRP must be listed on device labels or IFU and included in the UK Declaration of Conformity.
CE Marked devices: UKRP information is not required on labels, IFU, or Declaration of Conformity at this time. It can be voluntarily added, however.
Is there a UKRP symbol for labeling?
The MHRA has not released an official UKRP symbol. When required for UKCA Marked devices, you must use the text “UK Responsible Person” or “UKRP” in English on your labeling. This is similar to how the Australian TGA requires “Australian Sponsor” in text rather than a symbol.
How do I transfer my UKRP to Casus?
The transfer process is straightforward and typically takes 1-2 weeks. We guide you through each step, including MHRA notification and documentation updates. Learn more about the UKRP transfer process.
What are the upcoming changes to UKRP requirements?
The MHRA has proposed significant regulatory changes for 2026-2027, which will expand the UKRP’s role to align more closely with the EU Authorised Representative under MDR/IVDR. Proposed changes include:
- Requiring the UKRP to appoint a “Quality Person” (analogous to a “Person Responsible for Regulatory Compliance” under the MDR/IVDR), and
- Establishing UKRP product liability for the manufacturer’s defective devices.
We monitor these developments closely and will ensure your compliance as regulations evolve.
Ready to Enter the UK Market?
Get your custom quote and timeline for UK Responsible Person services. Our team will assess your specific requirements and provide transparent pricing.
Questions about UKRP requirements? Contact our team.
