We're preparing to launch a dedicated UKRP service for non-UK manufacturers.
Register your interest and be among the first to onboard.
Who We Help
EU, UK, and FDA market experience across Class I–III medical devices and SaMD.
Hands-on experience supporting MHRA registration and post-market obligations in Great Britain.
Aligned with ISO 13485 principles — systematic, documented, and audit-ready.
Not just registration — we provide ongoing compliance support as your device and market presence evolve.
Key takeaway: If you are a non-UK manufacturer, a UK Responsible Person is legally required to sell your device in Great Britain.
What Is a UKRP?
Following Brexit, Great Britain operates its own medical device regulatory framework under the MHRA (Medicines and Healthcare products Regulatory Agency). The UK Medical Devices Regulations 2002 (as amended) require that any manufacturer based outside the UK — whether in the EU, US, or anywhere else — must have a designated UK Responsible Person.
The UK Responsible Person (UKRP) is a UK-based individual or organisation that has defined regulatory responsibilities under UK MDR 2002 on behalf of the manufacturer. They are named on the MHRA device registration and act as the primary contact point for the regulator.
This is a legal requirement. Without a registered UKRP, your device cannot be legally placed on the Great Britain market (England, Scotland, Wales). Northern Ireland follows separate rules under the Windsor Framework.
The UKRP does not replace the manufacturer but acts as their regulatory representative in Great Britain.
Who Needs This?
You need a UK Responsible Person if you are a medical device manufacturer based outside the UK and you want to sell — or are already selling — in Great Britain.
You already have an EU MDR-compliant device. Now you want to access the UK market. EU registration and a CE mark are not sufficient for Great Britain — you need a separate UKRP and MHRA registration.
US, Canadian, Australian, or other non-EU manufacturers that want to enter the UK market. The requirement applies regardless of your home country's regulatory framework.
Early-stage companies expanding beyond their home market. A UKRP gives you the regulatory foothold you need in the UK without establishing a local entity.
What to Expect
When we launch, becoming UK market-ready with a UKRP will follow four steps.
We review your device, classification, and documentation to determine readiness for MHRA registration.
We formalise the UKRP role via a written agreement. Regvo is named as your UK Responsible Person.
We handle submission and all communication with the MHRA on your behalf.
We act as your UK regulatory contact and support vigilance obligations as they arise.
Pricing
Every UKRP engagement is different. Pricing will depend on your device class, regulatory complexity, and the level of support you need — from registration only through to full ongoing compliance coverage.
We'll keep things simple: clear scope, no hidden fees, and a structured approach aligned with regulatory best practice.
Register your interest below — we'll share pricing details as soon as they're finalised and let you know when onboarding opens.
The UKRP service is launching soon. Leave your details and we'll be in touch when onboarding opens.
No obligation. We'll reach out as soon as the service is ready.
Regvo is a UK-based regulatory consultancy supporting medical device companies with EU, UK, and FDA pathways.
Led by a Regulatory Affairs specialist with 10+ years experience, we provide practical, compliant support tailored to early-stage and scaling companies.