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UK Responsible Person (UKRP) for Medical Devices

Appoint a qualified UK Responsible Person (UKRP) to support regulatory compliance for your medical devices and IVDs in Great Britain. Cert3Global provides structured UKRP services for non-UK manufacturers, supporting MHRA registration, documentation management, and regulatory communication.

Our approach focuses on regulatory clarity, defined responsibilities, and ongoing compliance support—helping you navigate UK requirements effectively.

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UK Market Access for Medical Devices

Following the UK’s regulatory framework under UK MDR 2002, manufacturers based outside Great Britain must appoint a UK Responsible Person to place medical devices and IVDs on the market.

The UKRP serves as a legally designated representative in the UK and plays a key role in supporting regulatory compliance, maintaining documentation access, and acting as a communication bridge with the MHRA.

Cert3Global provides UKRP services designed specifically for medical devices, ensuring clear separation between regulatory roles and consulting services.

What is a UK Responsible Person (UKRP)?

A UK Responsible Person (UKRP) is a UK-based legal entity appointed by a non-UK manufacturer to act on its behalf in relation to regulatory obligations.

The UKRP does not manufacture or approve products but supports compliance by:

  • Acting as the primary contact with the MHRA
  • Supporting registration of devices in the UK
  • Maintaining access to technical documentation
  • Assisting with regulatory communication and updates

This role is mandatory for non-UK manufacturers placing medical devices or IVDs on the Great Britain market.

Key Responsibilities of a UK Responsible Person

A UKRP has defined regulatory responsibilities under UK MDR 2002. These typically include:

1. MHRA Registration Support

  • Submission of device details through MHRA systems
  • Coordination of registration data and updates

2. Technical Documentation Accessibility

  • Ensuring technical documentation is available for inspection
  • Providing access to MHRA when requested

3. Regulatory Communication

  • Acting as the official point of contact with MHRA
  • Responding to regulatory queries and notifications

4. Post-Market Surveillance Support

  • Assisting with vigilance reporting and incident communication
  • Supporting corrective actions and regulatory updates

5. Compliance Coordination

  • Working with manufacturers to maintain alignment with UK regulatory requirements

Our UKRP Services for Medical Devices

Cert3Global provides structured and clearly defined UKRP services, including:

MHRA Registration Coordination

Support with preparing and submitting device registrations through the MHRA DORS system.

Technical File Access & Management

Ensuring that documentation is accessible and maintained in line with regulatory expectations.

Regulatory Liaison

Handling communication with MHRA and supporting responses to queries or inspections.

Post-Market Compliance Support

Guidance on vigilance, incident reporting, and ongoing regulatory updates.

Documentation Review Support (Optional)

High-level review of documentation to identify gaps before registration submission.

What This Service Includes vs Does Not Include

Included

  • UK-based regulatory representation (when appointed)
  • MHRA communication support
  • Registration coordination
  • Documentation accessibility support

Not Included

  • Regulatory approval or certification
  • Guarantee of compliance outcomes
  • Acting as manufacturer, importer, or distributor
  • Full technical file creation (unless separately scoped)
This distinction is important to ensure transparency and avoid regulatory misunderstanding.

UKRP vs Other Regulatory Roles (Clarity Section)

To avoid confusion:
  • UK Responsible Person (UKRP) → UK-based representative for non-UK manufacturers
  • Manufacturer → legally responsible for product safety and compliance
  • Importer / Distributor → supply chain roles with separate obligations
Cert3Global clearly defines its role to avoid overlap or misinterpretation of responsibilities.

Who Needs a UK Responsible Person?

UKRP services are required for:
  • Non-UK manufacturers placing medical devices on the GB market
  • IVD manufacturers exporting to Great Britain
  • Companies expanding into the UK market post-Brexit
If your business is located outside the UK and you intend to supply devices in Great Britain, appointing a UKRP is mandatory.

UKRP Appointment Process

A typical UKRP onboarding process includes:
  • Agreement and appointment of UKRP
  • Review of product scope and documentation
  • Coordination for MHRA registration
  • Establishment of communication channels
  • Ongoing compliance support and monitoring

Why Choose Cert3Global for UKRP Services?

Cert3Global provides structured and transparent UKRP services tailored to medical device regulations.
We offer:
  • Clear definition of regulatory roles
  • Experience with UK MDR 2002 requirements
  • Support for MHRA registration processes
  • Reliable communication and documentation handling
  • Ongoing compliance guidance
Our focus is on helping manufacturers manage regulatory obligations efficiently while maintaining clarity and control over their compliance responsibilities.

Start Your UKRP Appointment

Appointing a UK Responsible Person is a key step in accessing the UK market. Cert3Global supports manufacturers throughout the process, helping ensure that regulatory requirements are properly addressed.
Book a Free 15-Minute Compliance Call

FAQs

Is a UK Responsible Person mandatory?
Yes, non-UK manufacturers must appoint a UKRP to place medical devices on the Great Britain market.
No. The UKRP does not approve or certify products. The manufacturer remains responsible for compliance.
The UKRP must ensure that documentation is accessible for regulatory review when required.
You cannot legally place medical devices on the GB market without a UKRP.
Yes, the requirement applies to both medical devices and in vitro diagnostic devices.

Disclaimer

Cert3Global provides UK Responsible Person and regulatory support services where formally appointed. Regulatory compliance, approvals, and market access outcomes remain the responsibility of the manufacturer and are subject to applicable UK laws and MHRA requirements.