Understanding the Role of UK Responsible Person (UKRP) for Medical Devices: Requirements, Responsibilities & Compliance

Manufacturers outside the United Kingdom must appoint a UK Responsible Person (UKRP) to place Medical Devices on the Great Britain market. The UKRP acts as the manufacturer’s regulatory representative and primary contact with the Medicines and Healthcare products Regulatory Agency (MHRA), performing duties defined under the UK Medical Devices Regulations 2002, including device registration, documentation oversight, and regulatory communication.

Ensuring Compliance in the UK Medical Device Market 

The United Kingdom’s Medical Device regulatory landscape changed significantly following Brexit, requiring new regulatory pathways for Medical Device UK market entry. One of the most important regulatory requirements introduced is the appointment of a UK Responsible Person (UKRP) for manufacturers located outside the UK.

The UKRP acts as the regulatory liaison between overseas manufacturers and the Medicines and Healthcare products Regulatory Agency (MHRA), ensuring compliance with UK Medical Device regulations.² This article explores the requirements, responsibilities, and compliance of UKRP obligations based on official regulatory guidance.

What is a UK Responsible Person (UKRP)?

A UKRP is a UK regulatory representative appointed by a non-UK manufacturer to act on its behalf in fulfilling regulatory obligations for placing Medical Devices on the Great Britain market (England, Scotland, and Wales).² This implies that manufacturers located outside the UK cannot directly place Medical Devices on the UK market unless they appoint a UKRP to represent them in regulatory matters.

Why is a UK Responsible Person (UKRP) Required?

The UKRP ensures that non-UK manufacturers comply with regulatory requirements and maintain direct communication with the UK regulatory authority. According to UK regulatory guidance:²

• Non-UK manufacturers must appoint a single UKRP for their devices before placing them on the UK market.
• The UKRP becomes the official contact point between the manufacturer and the MHRA.
• The UKRP manages device registration and regulatory communications.

Responsibilities of a UK Responsible Person (UKRP)

The responsibilities of UKRP are defined under the UK Medical Devices Regulations 2002 and monitored by the MHRA.²

1. Device Registration with MHRA

Before a Medical Device can be marketed in Great Britain, the UKRP must register the manufacturer and its devices with the MHRA regulatory requirements through the device registration UKRP system. This step is mandatory for non-UK manufacturers entering the UK market.

2. Verification of Regulatory Documentation

The UKRP must verify that the manufacturer has prepared the necessary regulatory documentation, including:

• The Declaration of Conformity
• Complete technical documentation
• Evidence that the appropriate conformity assessment procedure has been conducted, where required

3. Maintaining Technical Documentation

The UKRP must keep copies of key regulatory documents available for inspection by the MHRA, including:

• Technical documentation
• Declaration of Conformity
• Relevant conformity certificates and updates

These documents must be readily accessible if requested by regulators.

4. Providing Information to the MHRA

If requested by the MHRA, the UKRP must provide all relevant documentation and information demonstrating device compliance with UK regulations.

5. Facilitating Access to Devices

If the UKRP has access to device samples, they must provide them to the MHRA upon request. If the UKRP does not have direct access to the device, they must:

• Inform the manufacturer of the request
• Notify the MHRA whether the manufacturer will comply with the request

6. Cooperation on Safety and Corrective Actions

The UKRP must cooperate with the MHRA on preventive or corrective actions, such as safety updates, recalls, or risk mitigation measures.

7. Complaint and Incident Communication

If the UKRP receives complaints or reports of suspected device incidents from healthcare professionals, patients, or users, they must immediately inform the manufacturer

8. Regulatory Escalation if Manufacturer Fails to Comply

If the manufacturer fails to meet its regulatory obligations under UK Medical Device regulations, the UKRP must:

• Terminate their legal relationship with the manufacturer
• Inform the MHRA and any relevant approved body

9. Labelling Requirements

For devices bearing the UK Conformity Assessed (UKCA) mark, the name and address of the UKRP must appear on the device label, outer packaging, or instructions for use. This requirement ensures traceability and regulatory accountability.

UKRP vs EU Authorised Representative

After Brexit, manufacturers selling devices in both regions may need two regulatory representatives (Table 1). Notably, Northern Ireland is not covered by the UKRP framework; under the EU MDR 2017/745 continues to apply there, meaning an EU Authorised Representative is required for the Northern Ireland market. Manufacturers distributing across Great Britain, Northern Ireland, and the EU must therefore comply with both regulatory systems.”.³

UKRP: UK Responsible Person, EUAR: European Union Authorised Representative, MHRA: Medicines and Healthcare products Regulatory Agency, UK MDR 2002: United Kingdom Medical Devices Regulations 2002, EU MDR 2017/745: European Union Medical Device Regulation 2017/745, UKCA: UK Conformity Assessed, CE: Conformité Européenne.

Table 1: Key differences between the UK responsible person and EU authorised representative.

Conclusion

The UKRP for Medical Devices plays a critical role in the UK’s Medical Device regulatory framework. They function as the official representative of non-UK manufacturers and ensure regulatory compliance, facilitate device registration, and serve as the primary liaison with the MHRA.

For international manufacturers seeking entry into the UK Medical Device market, appointing a qualified UKRP is essential for ensuring regulatory compliance, market access, and patient safety.

References 

1. Lythgoe MP, Krell J, Bower M, et al. From the European Medicines Agency to Project Orbis: new activities and challenges to facilitate UK oncology drug approval following Brexit. Lancet Oncol. 2023;24(4):e150-e160. doi:10.1016/S1470-2045(22)00701-X

2. Regulating Medical Devices in the UK. GOV.UK. February 20, 2026. Accessed March 9, 2026. https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

3. Register Medical Devices to place on the market – GOV.UK. Accessed March 9, 2026. https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market