UK Rep - UK Responsible Person (UKRP)

The UK medical device regulatory framework is evolving, and the role of the UK Responsible Person (UKRP) is becoming increasingly important.

In Great Britain (England, Scotland and Wales), medical devices and in vitro diagnostic medical devices (IVDs) are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) under the UK Medical Devices Regulations 2002 (as amended). A program of phased regulatory reform is underway, with new post‑market surveillance requirements already in force and further pre‑market and IVD‑specific regulations expected in 2026.

For manufacturers established outside the UK, appointing a UK Responsible Person is a legal requirement to place devices on the Great Britain market. The UKRP acts as the manufacturer’s regulatory representative and primary contact with the MHRA, supporting device registration, compliance, and post‑market obligations throughout the product lifecycle.

Our UKRP service is designed to support manufacturers at every stage of the product lifecycle, from initial market entry through ongoing compliance. Our support includes:

• UK Responsible Person appointment
• Review and maintenance of regulatory documentation
• MHRA manufacturer and device registration
• Regulatory liaison with the MHRA on your behalf
• Support with vigilance, post‑market surveillance, and corrective actions
• Ongoing guidance as UK regulatory requirements evolve

By combining regulatory expertise with continuity of support, we help more than 350 manufacturers maintain compliant and uninterrupted access to the Great Britain market as the UK regulatory framework continues to develop.

A UK Responsible Person (UKRP) is a UK‑established entity legally appointed by a manufacturer located outside the United Kingdom to act on its behalf for regulatory purposes in Great Britain.

The requirement to appoint a UKRP is set out in the UK Medical Devices Regulations 2002 (as amended) and applies to all medical devices and in vitro diagnostic medical devices (IVDs) placed on the Great Britain market by non‑UK manufacturers. The UK Responsible Person serves as the manufacturer’s official regulatory representative and primary point of contact with the Medicines and Healthcare products Regulatory Agency (MHRA).

The UKRP role is similar in concept to the EU Authorized Representative but operates under UK‑specific legislation and obligations. A distributor or importer cannot automatically act as a UK Responsible Person unless they are formally appointed and meet the legal requirements of the role.

When is a UK Responsible Person Required?

A UK Responsible Person is required whenever a medical device or IVD is placed on the Great Britain market by a manufacturer that is not established in the UK, regardless of device class or conformity marking.

Specifically, a UK Responsible Person must be appointed when:

• • The manufacturer is located outside Great Britain, and
  • The device is supplied to or made available on the market in England, Scotland or Wales, and
• The device is CE‑marked under accepted transitional arrangements or UKCA‑marked.

The requirement applies equally to:

• Medical devices and IVDs
• All risk classes
• Devices placed on the market under transitional acceptance of CE marking or under UKCA conformity

It is important to note that Northern Ireland is subject to different rules under the Windsor Framework.

Medical devices and in vitro diagnostic medical devices (IVDs) placed on the Great Britain (GB) market are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) under the UK Medical Devices Regulations 2002 (UK MDR 2002), as amended.

While the UK MDR 2002 is still largely based on the former EU medical device directives, the regulatory framework is undergoing a phased reform program. These reforms are being introduced through secondary legislation to strengthen patient safety, improve post‑market oversight, and modernize pre‑market requirements, while maintaining continuity of supply.

Transitional Acceptance of CE Marking in Great Britain

CE‑marked medical devices and IVDs continue to be accepted in Great Britain under extended transitional arrangements introduced by the UK government (see infographics below). Under the current framework:

• CE‑marked devices compliant with EU MDR or EU IVDR may be placed on the GB market until at least 30 June 2030
• UKCA marking is available but not yet mandatory for most medical devices and IVDs
• The MHRA has consulted on proposals to indefinitely recognize CE‑marked devices in Great Britain, signaling continued reliance on international regulatory alignment.

Manufacturers placing CE‑marked devices on the GB market during this period must still comply with UK‑specific requirements, including MHRA registration and appointment of a UK Responsible Person. 

Under the UK Medical Devices Regulations, the UK Responsible Person acts as the regulatory link between the manufacturer and the MHRA and supports compliance throughout the device lifecycle.

Key responsibilities of the UK Responsible Person include:

• Registering the manufacturer and devices with the MHRA and maintaining registration data
• Holding copies of the manufacturer’s technical documentation and declarations of conformity
• Providing information or documentation to the MHRA upon request, within required timeframes
• Acting as the MHRA’s primary point of contact for regulatory and compliance matters
• Cooperating with the manufacturer on vigilance, complaints handling, and post‑market surveillance activities
• Supporting field safety corrective actions, including communication with the MHRA where required
• Informing the MHRA if the UKRP relationship is terminated due to non‑compliance by the manufacturer

With the introduction of strengthened post‑market surveillance requirements, the UK Responsible Person plays an increasingly important role in ensuring that regulatory documentation, registrations, and safety processes remain current and aligned with MHRA expectations.

Device Labelling Requirements for the Great Britain Market

UK‑specific labelling requirements also apply. Where required, the name and address of the UK Responsible Person must be included on the device label, packaging, or accompanying documentation. These requirements apply for UKCA‑marked devices, also if they bear both the UKCA-marking and CE-marking.

Great Brittain and Northern Ireland: Key Regulatory Differences

The UK medical device regulatory framework differs between Great Britain and Northern Ireland, and manufacturers must take this distinction into account when planning market access.

Regulatory reform in Great Britain is being introduced in stages:

• Post‑Market Surveillance (PMS):
  New statutory requirements strengthening vigilance, incident reporting, and PMS system expectations came into force in June 2025 and apply to all medical devices and IVDs placed on the GB market
• Future Pre‑Market Regulations:
  Further legislation is planned to introduce updated pre‑market requirements, including international reliance routes, classification changes, and strengthened technical documentation obligations. These changes are expected to enter into force in 2026, following consultation and parliamentary approval

As these changes are implemented, the MHRA has indicated increased regulatory scrutiny and clearer allocation of responsibilities across manufacturers, UK Responsible Persons, importers, and distributors.