Our UK Responsible Person (UKRP) service gives non-UK manufacturers a compliant, reliable route to the Great Britain market. We register your devices with the MHRA, hold your full technical documentation, and act as your point of contact with the regulator, so you can focus on your products.
UK Responsible Person (UKRP):
Manufacturers based outside the UK must appoint a single UK Responsible Person to place medical devices and IVDs on the Great Britain market.
Qualisure Consulting Ltd is a UK-established company registered with the MHRA, and can act as your UK Responsible Person under the UK Medical Devices Regulations 2002 (as amended).
We act on your behalf with the MHRA for CE-marked and UKCA-marked devices, supported by a written Letter of Designation.
Our name and address can be provided for UKCA labelling, outer packaging or instructions for use where required.
MHRA Device Registration:
Registration of your organisation and devices on the MHRA Device Online Registration System (DORS) before they are placed on the GB market.
Upload and maintenance of your Letter of Designation.
Ongoing updates as devices are added, changed or withdrawn, so your registrations stay current.
Guidance on MHRA registration fees and annual fee requirements.
Full Technical Documentation:
Verification that your declaration of conformity and technical documentation have been drawn up, and that the appropriate conformity assessment has been carried out.
A current copy of your technical documentation, declaration of conformity and certificates held ready for MHRA inspection.
Gap analysis, preparation and remediation of technical files to UK MDR, EU MDR and IVDR requirements through our Regulatory Services.
Prompt, well-organised responses to MHRA requests for information and documentation.
Post-Market Surveillance & Vigilance:
Complaints and suspected incident reports from UK healthcare professionals, patients and users passed to you immediately.
Cooperation with the MHRA on field safety corrective actions and other preventive or corrective measures.
Support with the GB post-market surveillance requirements in force since 16 June 2025, including PMS plans, vigilance reporting and periodic reports.
Coordination of MHRA requests for device samples or access.
Why Choose Qualisure as your UKRP?
20 years of medical device quality and regulatory experience, including notified body auditing.
A UKRP that understands your technical documentation, not just a UK address.
Direct access to a senior consultant, with clear and timely communication.
Integrated support across QMS auditing, regulatory services and MDSAP preparation, under one provider.
Talk to us about appointing Qualisure as your UK Responsible Person. We will confirm the scope for your device portfolio and provide a clear annual fee. See our consultancy rates for related services.