UK Responsible Person
As of 1st January 2022, manufacturers based outside the UK are legally required to appoint a UK Responsible Person (UKRP) to act on their behalf to place devices on the market in Great Britain (England, Wales and Scotland).
How can we help?
How can we help?
Following UK MDR 2002, as your UKRP, Russell Regulatory Consultants’ responsibilities are to:
- Register your devices with the MHRA
- Ensure the Declaration of Conformity and Technical documentation has been drawn up
- Keep available a copy of technical documentation, declaration of conformity and any relevant certificates for inspection by MHRA
- Provide information to MHRA upon request
- Where samples of the devices or access to the device is available, comply with any request from the MHRA to provide such samples or access to the device
- Where neither samples of the device nor access to the device is available, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed
If the manufacturer acts contrary to its obligations under these Regulations:
- terminate the legal relationship with the manufacturer; and
- inform the MHRA and, if applicable, the relevant Approved Body of that termination.
Source: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#uk-responsible-person
Following UK MDR 2002, as your UKRP, Russell Regulatory Consultants’ responsibilities are to:
- Register your devices with the MHRA
- Ensure the Declaration of Conformity and Technical documentation has been drawn up
- Keep available a copy of technical documentation, declaration of conformity and any relevant certificates for inspection by MHRA
- Provide information to MHRA upon request
- Where samples of the devices or access to the device is available, comply with any request from the MHRA to provide such samples or access to the device
- Where neither samples of the device nor access to the device is available, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed
If the manufacturer acts contrary to its obligations under these Regulations:
- terminate the legal relationship with the manufacturer; and
- inform the MHRA and, if applicable, the relevant Approved Body of that termination.
Source: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#uk-responsible-person
Why choose Russell Regulatory as your UKRP?
Why choose Russell Regulatory as your UKRP?
- Critically evaluating your technical documentation
- Identifying any gaps relating to specific disease states, risk management or patient demographics
- Providing insight into how devices work in practice, as well as alternative therapies, in their specific experience
- Giving their individualised feedback on clinical benefits and claims set out by you, the manufacturer
- Advising on their clinical expectation of your devices
- Advising on any ‘off-label’ use of devices they are aware of
- Providing up-to-date advice on state-of-the-art practice within their field