UK Responsible Person (UKRP) & MHRA Device Registration

Manufacturers based outside the UK must appoint a UK Responsible Person (UKRP) before placing medical devices or IVDs on the Great Britain market. The UK Responsible Person registers your devices with the MHRA and acts as your contact with the UK regulator. MedDeviceCorp provides UK Responsible Person services from a UK-registered office, handles MHRA device registration and supports your post-market duties, so your devices can be sold in England, Scotland and Wales.

We support manufacturers from the United States, India, South Korea, Japan, Europe and other countries entering the UK market.

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What Does a UK Responsible Person Do?

The UK Responsible Person takes on legal responsibilities on behalf of a non-UK manufacturer. As your UK Responsible Person, we:

  • Confirm that your declaration of conformity and technical documentation exist, and that the required conformity assessment was carried out
  • Keep copies of these documents available for MHRA inspection
  • Register your devices with the MHRA before they are placed on the GB market
  • Give the MHRA information, samples or access to devices on request
  • Cooperate with the MHRA on corrective and preventive actions
  • Pass complaints and incident reports from UK users to you without delay

If a manufacturer acts against its legal obligations, the UK Responsible Person must end the relationship and inform the MHRA. Choosing a reliable, well-informed UKRP protects your access to the UK market. MHRA – Regulating medical devices in the UK

UK Responsible Person Requirements Checklist

Use this checklist to confirm you meet the UK Responsible Person requirements before placing devices on the GB market:

  • One UK Responsible Person appointed, with a registered place of business in the UK
  • Signed letter of designation (written mandate) between manufacturer and UKRP
  • Declaration of conformity and technical documentation available to the UKRP
  • Valid CE or UKCA certificate, where a notified or approved body is required
  • Devices registered with the MHRA through the UKRP
  • UKRP name and address on the label, packaging or instructions for use if the device carries the UKCA mark
  • Process for passing complaints and serious incidents between the UKRP and the manufacturer
  • Post-market surveillance system that meets the Great Britain requirements in force since 16 June 2025

Who Needs a UK Responsible Person?

Non-UK Manufacturers

Any manufacturer based outside the UK that places medical devices, IVDs, custom-made devices or system and procedure packs on the Great Britain market must appoint one UK Responsible Person.

Importers and Distributors

UK importers and distributors do not need their own UKRP. They can act as the manufacturer's UK Responsible Person, but many manufacturers prefer an independent UKRP so their registration does not depend on a single distributor.

Northern Ireland

Northern Ireland follows the EU MDR and IVDR, and devices need the CE mark. A UKRP is not the route there; non-EU manufacturers need an EU Authorised Representative.

UK Representative, UK Authorised Representative or UK Responsible Person?

Manufacturers often search for a "UK representative" or "UK authorised representative" for medical devices. In Great Britain, the legal role is the UK Responsible Person, defined in the UK Medical Devices Regulations 2002. Before Brexit, GB-based authorised representatives acted for manufacturers under EU rules; those MHRA accounts had to be converted to UK Responsible Person status. The EU equivalent is the EU Authorised Representative, which is still needed for the EU and Northern Ireland markets.

UK Responsible Person Letter of Designation

To register your devices, the UK Responsible Person must give the MHRA written evidence that the manufacturer has appointed it. This letter of designation (or written mandate) usually includes:

  • Full legal names and addresses of the manufacturer and the UK Responsible Person
  • The devices or device groups covered by the appointment
  • The tasks the UKRP will carry out, in line with UK MDR
  • Start date, signatures and the conditions for ending the appointment

We prepare the letter of designation for you as part of our UK Responsible Person service.

MHRA Medical Device Registration

All medical devices must be registered with the MHRA before they are placed on the Great Britain market. This includes IVDs, custom-made devices and system or procedure packs. UK-based manufacturers register directly, while non-UK manufacturers register through their UK Responsible Person. The MHRA charges a fee for each registration application.

For MHRA registration, we need:

  • Manufacturer name and address, and a signed UKRP letter of designation
  • Device names, models and risk classification
  • GMDN codes for each device
  • Declaration of conformity and, where applicable, the CE or UKCA certificate
  • Labels and instructions for use

A device already registered with the MHRA for the Northern Ireland market can be placed on the GB market without further registration.

CE Marked Devices in Great Britain: Key Dates

Great Britain still accepts CE marked medical devices for a transition period. Your UK Responsible Person must still register them with the MHRA.

  • EU MDD or AIMDD devices: until the certificate expires or 30 June 2028, whichever comes first
  • EU IVDD devices: until the certificate expires or 30 June 2030, whichever comes first
  • EU MDR devices and EU IVDR devices: until 30 June 2030

Devices can also carry the UKCA mark, alone or together with the CE mark. The UK government has consulted on recognising CE marking for longer, so we keep your registrations aligned with the latest MHRA position.

UK Responsible Person Address and Symbol on Labels

When a device carries the UKCA mark, including devices with both UKCA and CE marks, the UK Responsible Person's name and address must appear on the label, the outer packaging or the instructions for use. For devices with only the CE mark, UKRP details on the label are not required. Importer or distributor details are not required unless they act as the UKRP.

UK MDR does not define a dedicated UKRP symbol in the way the EU uses an "EC REP" symbol. The clearest approach is to print the words "UK Responsible Person" or "UKRP" followed by our registered UK address. We confirm the exact wording for your labels when you appoint us.

UK Responsible Person for Software as a Medical Device (SaMD)

Software that qualifies as a medical device, including apps and AI-based software, follows the same rules as physical devices. A non-UK software manufacturer must appoint a UK Responsible Person and register the software with the MHRA before making it available in Great Britain. Where the software carries the UKCA mark, UKRP details are usually shown in the instructions for use or within the software's information screen.

Post-Market Surveillance in Great Britain

New post-market surveillance (PMS) requirements for medical devices came into force in Great Britain on 16 June 2025. Manufacturers must run a PMS system, report serious incidents to the MHRA within set deadlines and prepare regular safety reports for their devices. As your UK Responsible Person, we forward complaints and incident reports to you quickly and support your communication with the MHRA. MHRA – PMS guidance

How Our UK Responsible Person Service Works

  1. Review – we check your device classification, certificates and target market (GB or Northern Ireland).
  2. UKRP agreement – we sign a written mandate and issue a UKRP letter of designation.
  3. Document check – we confirm your declaration of conformity and technical documentation are complete.
  4. MHRA registration – we register your devices with the MHRA and share the confirmation.
  5. Labelling support – we confirm whether our UKRP details must appear on your labels.
  6. Ongoing support – complaints, incident reports and MHRA requests handled throughout the contract.

Why Choose MedDeviceCorp as Your UK Responsible Person?

We combine the UK Responsible Person role with hands-on regulatory knowledge of UK MDR, EU MDR and IVDR, so your UK registration is consistent with your EU and US compliance.

  • UK Responsible Person services from a UK-registered office
  • MHRA registration and updates handled for you
  • Support with technical documentation and clinical evaluation questions
  • One team for EU Representative and US FDA Agent services

UK Responsible Person FAQs

What is a UK Responsible Person?

A UK Responsible Person (UKRP) is a UK-based company or person appointed by a non-UK manufacturer to carry out legal tasks for its medical devices in Great Britain, including MHRA registration and contact with the MHRA.

Do I need a UK Responsible Person?

Yes, if your company is based outside the UK and you want to place medical devices or IVDs on the Great Britain market.

Who can act as a UK Responsible Person?

Any person or company with a registered place of business in the UK that accepts the legal responsibilities, including a UK importer or distributor or an independent service provider.

Can a non-UK manufacturer sell medical devices in Great Britain without a UKRP?

No. A manufacturer based outside the UK must appoint a UK Responsible Person before placing devices on the Great Britain market.

Does the UKRP name have to be on the device label?

Only when the device carries the UKCA mark, including dual CE and UKCA marked devices. Then the UKRP name and address must be on the label, outer packaging or instructions for use.

Are CE marked devices still accepted in the UK?

Yes, for a transition period. EU MDD and AIMDD devices until 30 June 2028 or certificate expiry, EU IVDD devices until 30 June 2030 or certificate expiry, and EU MDR and IVDR devices until 30 June 2030.

Can my UK distributor act as my UKRP?

Yes, an importer or distributor can act as UKRP if it accepts the legal responsibilities. Many manufacturers choose an independent UKRP to keep control of their registration.

Does the UKRP need my technical documentation?

The UKRP must confirm your technical documentation and declaration of conformity exist and keep them available for MHRA inspection, so a current copy is needed.

Do I need a UKRP for Northern Ireland?

No. Northern Ireland follows EU rules. Manufacturers outside the EU need an EU Authorised Representative for the Northern Ireland market.

Appoint MedDeviceCorp as Your UK Responsible Person

Get your UK Responsible Person appointed and your devices registered with the MHRA, with one regulatory team supporting you.

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