If you're a non-UK manufacturer planning to sell medical devices in Great Britain, a UK Responsible Person is a legal requirement. This guide explains who needs one, what they do, and how to choose the right one.
Yes. Any non-UK manufacturer selling medical devices in Great Britain must appoint a UK Responsible Person before market access — regardless of CE marking or EU MDR compliance. The UK is a separate regulatory jurisdiction post-Brexit. Your UKRP must be UK-based and registered with the MHRA, regardless of device classification.
Following Brexit, Great Britain (England, Scotland, and Wales) operates its own medical device regulatory framework under the MHRA. Under the UK Medical Devices Regulations 2002 (as amended), any manufacturer based outside the UK must have a designated UK Responsible Person (UKRP) before placing a device on the Great Britain market.
The UKRP is a UK-based individual or organisation named on the MHRA device registration and responsible for defined regulatory obligations on behalf of the manufacturer. They do not replace the manufacturer — they act as the manufacturer's regulatory representative in Great Britain.
Key point: Without a registered UK Responsible Person, your device cannot legally be placed on the Great Britain market. Northern Ireland follows separate rules under the Windsor Framework.
Yes. The requirement applies to any manufacturer based outside of Great Britain — including EU-based manufacturers, US manufacturers, and manufacturers from any other country — who wants to place medical devices on the Great Britain market.
CE marking alone is not sufficient for Great Britain. A separate UKRP and MHRA registration is required, regardless of whether your device is CE marked and MDR-compliant in the EU.
You already have an EU MDR-compliant device and CE marking. You now want to access the UK market. EU registration does not extend to Great Britain — you need a UKRP and separate MHRA registration.
US, Canadian, Australian, or other non-EU manufacturers entering the UK market. The UKRP requirement applies regardless of your home country's regulatory framework or existing certifications.
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 yourself.
The UKRP takes on defined responsibilities under UK MDR 2002. These are not optional — they are legal obligations that the UKRP assumes on behalf of the manufacturer.
It does not. Since Brexit, Great Britain and the EU are separate regulatory jurisdictions. CE marking confirms compliance with EU requirements — it does not grant access to the Great Britain market. You need MHRA registration and a UKRP in addition to your CE mark.
No. The UKRP must be a UK-based individual or organisation. An EU-based distributor cannot fulfil this role, even if they distribute your product into the UK through a separate entity.
The UKRP requirement applies across device classes — including Class I devices. The specific registration requirements vary by class, but the obligation to have a UKRP is not class-dependent.
The UKRP reviews your device, its classification, and your existing documentation to determine readiness for MHRA registration.
The UKRP role is formalised via a written agreement. The UKRP is then named as your UK Responsible Person for the relevant device(s).
The UKRP handles the MHRA device registration submission and manages all communication with the regulator on your behalf.
The UKRP acts as your UK regulatory contact for the duration of the arrangement, including vigilance reporting obligations as they arise.
Because the UKRP takes on legal obligations on your behalf, choosing the right one matters. Key things to assess:
Appointing a UKRP is not a one-time formality. It is an ongoing regulatory relationship. Choose carefully and make sure the scope of responsibilities is clearly agreed in writing before you proceed.
Regvo acts as UK Responsible Person for medical device manufacturers entering the Great Britain market. Get in touch to discuss your device and receive a tailored quote within 24 hours.
Learn about our UKRP serviceYes. CE marking is not valid for the Great Britain market. Since Brexit, you need a separate UK Responsible Person and MHRA registration regardless of whether your device is CE marked and MDR-compliant in the EU. These are two independent requirements.
Any manufacturer based outside Great Britain — including EU, US, and other international manufacturers — who wants to place medical devices on the Great Britain market must appoint a UKRP. Northern Ireland follows separate rules under the Windsor Framework.
No. The UK Responsible Person must be a UK-based individual or organisation. An EU-based distributor cannot fulfil this role, even if they have operations in the UK. The UKRP must be physically established in Great Britain.
A UKRP must register the device with the MHRA on the manufacturer's behalf, verify compliance documentation, act as the MHRA's primary contact, support vigilance reporting, and maintain records for MHRA inspections. They take on legal obligations on behalf of the manufacturer.
Yes. Without a registered UK Responsible Person, your device cannot legally be placed on the Great Britain market. The UKRP must be appointed and the device must be registered with the MHRA before market access begins.