UK Responsible Person
ReguLogix Consulting is registered with the MHRA to provide UKRP services, ensuring full compliance with UK Medical Device Regulations.
Following the UK's departure from the European Union on January 31, 2020, with the transition period concluding on December 31, 2020, manufacturers of medical devices based outside of the UK must appoint a UK Responsible Person if they wish to market their devices in Great Britain (England, Scotland, and Wales, excluding Northern Ireland) starting January 1, 2021.
According to the UK Medical Devices Regulations 2002, the UK Responsible Person acts on behalf of the manufacturer and is responsible for specific duties, including:
Following the UK's departure from the European Union on January 31, 2020, with the transition period concluding on December 31, 2020, manufacturers of medical devices based outside of the UK must appoint a UK Responsible Person if they wish to market their devices in Great Britain (England, Scotland, and Wales, excluding Northern Ireland) starting January 1, 2021.
According to the UK Medical Devices Regulations 2002, the UK Responsible Person acts on behalf of the manufacturer and is responsible for specific duties, including:
- Registering the devices with the Medicines and Healthcare products Regulatory Agency (MHRA)
- Ensuring that the declaration of conformity and technical documentation are prepared, and that an appropriate conformity assessment procedure has been conducted by the manufacturer, if applicable
- Maintaining copies of the technical documentation, declaration of conformity, and relevant certificates, including any amendments and supplements, for inspection by the MHRA
- Providing the MHRA with all necessary information and documentation to demonstrate device conformity upon request
- Providing device samples to the MHRA or facilitating MHRA access to samples or forwarding requests for samples or access to the manufacturer if not available to the Responsible Person
- Cooperating with the MHRA on any preventive or corrective actions to manage device risks
- Promptly notifying the manufacturer of complaints, reports from healthcare professionals, patients, and users regarding suspected device-related incidents
In the event of manufacturer non-compliance:
- Terminating the legal relationship with the manufacturer
- Informing the MHRA and, if applicable, the relevant Approved Body of the termination
This appointment ensures compliance with UK regulations and facilitates market access for medical devices in Great Britain post-Brexit.
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