Selling Medical Devices in Great Britain? Why a UK Responsible Person Is Your Only Way In 2026

For a medical device manufacturer based outside the United Kingdom, appointing a UK Responsible Person (UKRP) is a key step before placing devices on the Great Britain market. The UKRP acts as the manufacturer’s local regulatory contact and carries out specific duties under the UK Medical Devices Regulations 2002 (UK MDR 2002). 

This article covers Great Britain: England, Scotland and Wales. Northern Ireland follows a different framework. 

Who Needs a UK Responsible Person?

A manufacturer established outside the UK must appoint one UKRP to act on its behalf for its medical devices intended for the Great Britain market. The manufacturer must provide written evidence of the appointment through a Letter of Designation. The letter is a legal agreement and should describe the UKRP’s required responsibilities. 

The UKRP submits the manufacturer’s device registration to the MHRA through the Device Online Registration System (DORS). Devices must be registered before they are placed on the Great Britain market. An importer or distributor does not have to appoint a UKRP, although an importer or distributor may also take on the UKRP role. 

What Does the UKRP Do? 

The UKRP’s responsibilities include: 

• Registering the manufacturer’s devices with the MHRA before market placement. 
• Ensuring that the Declaration of Conformity and technical documentation have been prepared and that the appropriate conformity assessment has been completed, where applicable. 
• Keeping copies of the technical documentation, Declaration of Conformity, and relevant certificates available for MHRA inspection. 
• Providing requested information or documentation to the MHRA and arranging access to device samples when requested. 
• Cooperating with the MHRA on preventive or corrective safety actions. 
• Promptly informing the manufacturer about complaints and suspected incidents. 
• Ending the legal relationship and notifying the MHRA and, where relevant, the Approved Body if the manufacturer fails to meet its obligations. 

The UKRP’s name and address must appear on the product labelling, outer packaging or instructions for use when a UKCA mark is used. This information is generally not required on the label for a CE-only device, unless the device carries both CE and UKCA marks. 

What a UKRP Appointment Does Not Mean 

UKRP appointment and MHRA registration are not product certification or approval. The manufacturer remains responsible for meeting the applicable safety, performance, and conformity requirements. MHRA registration confirms that the device has been entered in the registration system; it is not an endorsement by the MHRA. 

2026 Regulatory Updates to Note 

MHRA registration fees changed on 1 April 2026. For 2026/27, the annual fee is £300 for each GMDN Level 2 category in which a manufacturer has registered devices (or a Level 1 category where no Level 2 category exists). The fee is charged once per category, not once per model or product. Outstanding 2026/27 fees for devices placed on the market are due by 6 November 2026; accounts with unpaid fees after that date may be suspended. 

The MHRA’s published transitional dates for CE-marked devices remain category-specific: 

• EU MDD/AIMDD devices: until the earlier certificate expiry or 30 June 2028. 
• EU IVDD devices: until the earlier certificate expiry or 30 June 2030. 
• EU MDR/IVDR devices: until 30 June 2030. 

On 21 October 2026, the government announced that it would continue to accept CE-marked medical devices on a long-term basis. Manufacturers should follow the current MHRA guidance and applicable transition rules while the policy is implemented. 

The MHRA also consulted on draft pre-market changes in 2026, including proposals for international reliance, UDI, updated IVD classification, and stronger technical documentation requirements. These proposals should be treated as proposed changes unless and until brought into force. 

Choosing a UKRP 

Before appointing a UKRP, check that the provider understands the UK MDR 2002 and DORS process, can manage complaints and vigilance communications, and has a clear process for keeping the manufacturer’s registration and supporting records current. A change of UKRP requires a new MHRA registration, so agree with responsibilities and communication timelines in writing. 

How NexorTest Can Support Manufacturers 

NexorTest can support non-UK manufacturers with UKRP services, MHRA device registration and technical documentation review. Support can also be provided for planning a UKCA conformity assessment, where that route is relevant to the product.