Is a UK Responsible Person required for all UKCA devices?

Yes. Non-UK manufacturers placing UKCA-marked medical devices on the Great Britain market must appoint a UK Responsible Person (UKRP) established in the UK.

Does the same RP cover England, Scotland, and Wales?

Yes. A UK Responsible Person covers Great Britain (England, Scotland, Wales). Northern Ireland has different rules under the Windsor Framework and may require an EU representative.

What is the UKRP's responsibility with MHRA?

The UKRP is the official point of contact for the MHRA. They register your devices, handle recalls, respond to vigilance queries, and can act on your behalf in safety matters.

Can I switch UK Responsible Persons?

Yes. You can change your UKRP by submitting an updated appointment declaration to the MHRA. Your new UKRP will guide you through the transition.

How quickly can I appoint a UKRP?

Most providers onboard within 5–10 business days. Expedited onboarding is available from some providers if you have an upcoming MHRA deadline.

Appoint a UK Responsible Person for UKCA Medical Devices

Appoint a vetted UK Responsible Person (UKRP) for UKCA medical devices online. Compare annual fees and onboarding terms from qualified UK RP providers.

✓ 4 active providers available right now · GBP 800 – 1,368

Why this page is different

Instant pricing: See a price estimate immediately (no back-and-forth RFQ needed for these services).
Compare before booking: Review inclusions, exclusions, turnaround, and communication channels.
Charged only when accepted: You are charged only after a provider accepts your order and scope.
Live availability: 4 active providers available right now for this service.

What you can compare here

Total price: See live price ranges and instant pricing rules where available.
Coverage & scope: Markets served, what is included, and what is explicitly excluded.
SLA & responsiveness: Acceptance SLAs and typical turnaround windows.
Add-ons: Optional extras you can book next (shown as add-on chips).
Onboarding time: How quickly providers can start and what you need to supply.

Compare providers (instant pricing + book)

Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 1,200	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 1,368	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 1,104	24h	3–7 days	Within 2 business days
IQVVV	USD 800	12h	3–5 days	Within 2 business days

Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

billingPeriod (Required)
monthly|quarterly|annual
deviceClass (Required)
I|IIa|IIb|III
deviceFamiliesCount (Required)
min 1
legalEntitiesCount (Required)
min 1
includeMhRADeviceRegistrationSupport (Optional)
one-time or project add-on (provider-defined)
includeVigilanceLiaisonSupport (Optional)
recurring add-on
buyerNotes (Optional)

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Market

📋

Regulation

UK MDR 2002

⏱️

Onboarding

5–10 business days

💰

Pricing

Annual retainer

Want to read provider profiles and reviews first? Compare all UK Responsible Person providers →

How it works

1

Describe your device portfolio

Provide device class, number of families, legal entities, and whether you need MHRA registration support.
2

Compare UK RP providers with instant pricing

See annual fees, MHRA liaison scope, and turnaround from qualified UK Responsible Persons.
3

Appoint and receive your UKRP pack

Confirm your UK RP, who will issue your appointment letter and MHRA-facing documentation.

What is a UK Responsible Person (UKRP) for medical devices?

Since the UK left the EU, medical devices sold on the Great Britain market (England, Scotland, and Wales) are regulated by the MHRA under a post-Brexit framework that largely mirrors EU MDR and EU IVDR. Under this framework, any manufacturer established outside the UK must appoint a UK Responsible Person (UKRP) established in Great Britain before placing UKCA-marked devices on the GB market. The UKRP's name and address must appear on device labelling, and they are the MHRA's official point of contact for your establishment. Without a current UKRP on file, your UKCA registration cannot be maintained.

What does the UK Responsible Person do?

The UKRP has three core obligations: (1) registering and maintaining your device registrations in the MHRA registration system; (2) receiving and forwarding all official MHRA correspondence — including inspection notices, post-market surveillance queries, and vigilance requests — to your establishment promptly; and (3) cooperating with MHRA market surveillance activities, including Field Safety Corrective Actions (FSCAs). A proactive UKRP will also keep you informed of changes to UK medical device regulations, particularly as the UK diverges from EU frameworks over time, and ensure your MHRA registration renewal is handled on schedule.

How much does a UK Responsible Person cost?

Annual UKRP fees typically range from GBP 200 for a simple single-entity, single-device-family Class I portfolio to GBP 2,800 or more for complex, multi-family Class III portfolios. Most UKRPs charge a base annual retainer covering registration maintenance and correspondence forwarding, with optional add-ons for FSCA management, vigilance liaison, or post-market surveillance coordination. On Cruxi Bridge, you see itemized annual pricing based on your portfolio before committing — unlike the traditional RFQ process where you wait days for a response.

Northern Ireland: a different story

Northern Ireland is a critical nuance for UK device market access. Under the Windsor Framework, medical devices sold in Northern Ireland must still comply with EU MDR/IVDR rules and require an EU Authorized Representative (EC REP), not just a UKRP. If you supply into both Great Britain and Northern Ireland, you will typically need both a UKRP for GB and an EC REP for Northern Ireland. This dual-requirement situation catches many manufacturers off-guard, particularly those assuming that appointing a single UK RP covers the entire UK. Confirm your UKRP's scope at the point of booking.

Frequently asked questions

Is a UK Responsible Person required for all UKCA devices?: Yes. Non-UK manufacturers placing UKCA-marked medical devices on the Great Britain market must appoint a UK Responsible Person (UKRP) established in the UK.
Does the same RP cover England, Scotland, and Wales?: Yes. A UK Responsible Person covers Great Britain (England, Scotland, Wales). Northern Ireland has different rules under the Windsor Framework and may require an EU representative.
What is the UKRP's responsibility with MHRA?: The UKRP is the official point of contact for the MHRA. They register your devices, handle recalls, respond to vigilance queries, and can act on your behalf in safety matters.
Can I switch UK Responsible Persons?: Yes. You can change your UKRP by submitting an updated appointment declaration to the MHRA. Your new UKRP will guide you through the transition.
How quickly can I appoint a UKRP?: Most providers onboard within 5–10 business days. Expedited onboarding is available from some providers if you have an upcoming MHRA deadline.

How Cruxi Bridge vets providers

✓ Every provider submits regulatory expertise evidence and jurisdictional coverage claims
✓ Providers that go live agree to the Cruxi Bridge Provider Terms including service delivery and accuracy obligations
✓ Payment is held by Cruxi and only released to the provider after service delivery milestones
✓ Buyers can raise a dispute within 30 days — Cruxi reviews and mediates per the platform terms

Prices and provider availability are live and may change. Charged only when a provider accepts your order. ← All services