UKRP - Medical Devices

Responsible person in the UK

Following Brexit, as of 1 January 2021, the United Kingdom (UK) has implemented an independent medical device regulatory framework, separate from the European Economic Area (EEA).
As part of this framework, all non-UK manufacturers are required to appoint a UK-based UK Responsible Person (UKRP) in order to place medical devices on the UK market.

UK Responsible Person (UKRP) Responsibilities for Medical Devices

Obligations of the UK Responsible Person (UKRP) for Medical Devices
The obligations of the UK Responsible Person (UKRP) for medical devices are set out in the UK Medical Devices Regulations 2002 (UK MDR 2002), as amended and applicable from 1 January 2021.
In addition to device registration requirements, the UKRP must:
  • Ensure, where applicable, that the manufacturer has carried out the appropriate conformity assessment procedure;
  • Maintain access to a copy of the technical documentation and the Declaration of Conformity;
  • Retain and make available, where applicable, a copy of the relevant certificates, including any amendments or supplements, for inspection by the Medicines and Healthcare products Regulatory Agency (MHRA).

Obligations in the event of MHRA contact
Where contacted by the MHRA, the UKRP shall:
  • Provide all information and documentation necessary to demonstrate the compliance of the device;
  • Supply samples or grant access to devices, where samples are held or access is available;
  • Where samples or access are not available, notify the manufacturer of the MHRA’s request and inform the MHRA whether the manufacturer intends to comply;
  • Cooperate fully with the MHRA in relation to any preventive or corrective actions required to eliminate or, where not possible, mitigate risks posed by the device.
Obligations in the event of complaints or incident reports
In the event of a complaint or incident report, the UKRP is required to:
  • Immediately inform the manufacturer of any reports received from healthcare professionals, patients, or users regarding suspected incidents involving the designated device;
  • Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under the applicable regulations, and notify the MHRA and, where applicable, the relevant conformity assessment body of such termination.

Specialized UK Responsible Person (UKRP) Services for Medical Devices

Why choose a specialised UK Responsible Person (UKRP) instead of a distributor? 
Appointing a distributor as your UK Responsible Person may appear to be the simplest solution, but it is not always the most appropriate or strategic choice.

By working with a specialised and independent UKRP, manufacturers retain full control over regulatory compliance and market access, while preserving flexibility in how their medical devices are commercialized and distributed in the UK.

A dedicated UKRP operates exclusively in the manufacturer’s regulatory interest, ensuring clear separation between regulatory responsibilities and commercial activities.

Our UK Responsible Person (UKRP) Services for Medical Devices

Our UK Responsible Person (UKRP) Services for Medical Devices

In its role as UK Responsible Person (UKRP), MDQ Services Ltd provides comprehensive regulatory support to medical device manufacturers, including:
  • Support in understanding and complying with UK and applicable European medical device requirements, including data submission and management within the MHRA registration system;
  • Identification of national language requirements applicable to medical devices placed on the UK market;
  • Identification of national medical device registration requirements and, where permitted, completion of the registration process on behalf of the manufacturer;
  • Registration of client medical devices on the MHRA database;
  • Liaison with Approved Bodies and other relevant organisations for activities related to the UKCA marking process;
  • Acting as the official regulatory point of contact with UK authorities, including the MHRA;
  • Receipt, management, and transmission of information relating to vigilance, adverse events, and field safety corrective actions, including notification to the relevant competent authorities;
  • Maintenance of access within the UK to technical documentation, clinical evaluation reports, and certificates, as required by applicable regulations.
MDQ Services Ltd provides UKRP services tailored to the specific needs, device portfolio, and regulatory strategy of each client.
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MDQ’s UK Responsible Person (UKRP) Services Are Designed to Be:

Tailored

The UKRP role is provided under an annual service fee, reflecting the regulatory responsibilities associated with the appointment.
Fees are structured according to the number of product families.
All activities are clearly defined and detailed in a transparent and accurate quotation.

Performance-Driven

We support post-market surveillance activities, including performance monitoring and regulatory reporting.
Our team understands the importance of data-driven oversight and knows where to access and interpret the relevant information to ensure ongoing compliance.

Fully Compliant

One of our qualified regulatory engineers will oversee the conformity of your medical devices.
Device compliance is systematically verified in accordance with UK regulatory requirements, ensuring robust and reliable regulatory oversight.

Looking for a UK Responsible Person (UKRP) for your medical devices?
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We take the time to understand your specific needs in order to deliver the most appropriate solution.
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