UK Responsible Person

ReguLogix Consulting is registered with the MHRA to act as UK Responsible Person for manufacturers outside Great Britain — ensuring seamless post-Brexit compliance with the UK Medical Devices Regulations 2002

What We Provide

MHRA-Registered UKRP Services

MHRA Device Registration

Acting as your UK Responsible Person, we register your medical devices with the MHRA on your behalf, enabling lawful placement on the Great Britain market under UK MDR 2002

Technical Documentation

Maintaining copies of technical documentation, declarations of conformity, and relevant conformity assessment certificates — all ready for immediate MHRA inspection upon request

Ongoing Regulatory Compliance

Promptly notifying manufacturers of complaints and suspected incidents, cooperating with MHRA on preventive or corrective actions, and managing device risk throughout its lifecycle

UKRP Duties Under UK MDR 2002

Responsibilities We Fulfil on Your Behalf

  • Registering devices with the Medicines and Healthcare products Regulatory Agency (MHRA)
  • Ensuring the declaration of conformity and technical documentation are prepared, with appropriate conformity assessment conducted
  • Maintaining copies of technical documentation, declarations of conformity, and relevant certificates for MHRA inspection
  • 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
  • Cooperating with the MHRA on any preventive or corrective actions to manage device risks
  • Promptly notifying the manufacturer of complaints, reports, and suspected device-related incidents
  • In the event of manufacturer non-compliance — terminating the legal relationship and informing the MHRA and relevant Approved Body
Post-Brexit requirement: Following the UK's departure from the EU on 31 January 2020, manufacturers based outside the UK must appoint a UK Responsible Person to market devices in England, Scotland, and Wales from 1 January 2021
MHRA Registered
Authorised UK
Responsible Person
GB Market Access
England, Scotland, & Wales Complaint
UK MHRA 2002 Aligned
Full regulatory obligations fulfilled
End-to-End Service
From strategy through to market approval

Get in Touch with Us

Discover the flexible ways you can engage with our services based on your company's specific requirements. 
We offer the following options, which can be customised to align perfectly with your business needs:

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