UK Responsible Person (UKRP) for MDR Compliance

Bespoke Solutions for UK Medical Device Compliance

Ready to Enter the UK Market?

At Eomi Consultancy, we provide dedicated UK Responsible Person (UKRP) services to help ensure your company and products fully comply with the UK MDR 2002, enabling a seamless and compliant entry into the UK market.

We understand the complexities of navigating Medical Device Regulations

UK Responsible Person ensuring MDR compliance
  • Appoint a UK Responsible Person (UKRP)
  • Device Registration with MHRA
  • Conformity Assessment
  • UKCA Marking
  • Labeling and Instructions Compliance
  • Post-Market Surveillance
  • Reporting of Serious Incidents
  • Maintenance of Technical Documentation
  • Market Withdrawal/Recalls
  • Compliance with Traceability Requirements
  • Cooperate with MHRA
MHRA registration process for medical devices
  • Liaising with the UK MHRA (Medicines and Healthcare Products Regulatory Agency)
  • Ensure Regulatory Compliance
  • Conformity Assessment
  • Device Registration with the MHRA
  • Labeling and Instructions for Use Compliance
  • Post-Market Surveillance
  • Market Withdrawal/Recalls
  • Maintain Technical Documentation
  • Notifying the MHRA of Serious Incidents
  • Ensuring Traceability
  • Assist in Clinical Trials (if applicable)
  • Compliance with UKCA Marking

What is a UK Responsible Person (UKRP) for Medical Devices?

  • A UK Responsible Person (UKRP) is legally required for foreign manufacturers selling medical devices in the UK.
  • UKRP ensures compliance with UK Medical Device Regulations (UK MDR 2002) and MHRA registration.

Why Do You Need a UK Responsible Person for MDR Compliance?

  • Legal requirement: MDR mandates UKRP for non-UK medical device manufacturers.
  • MHRA compliance: UKRP handles device registration, regulatory submissions, and post-market surveillance.
  • Market access: Without a UKRP, your medical devices cannot be sold in the UK

Our UKRP Services for Medical Device Compliance

  • MHRA Registration & Device Listing – Ensuring compliance with UK regulations.
  • Regulatory Compliance & Documentation Review – Assisting with technical files & conformity assessment.
  • Post-Market Surveillance & Vigilance Reporting – Handling complaints, adverse incidents & recalls.
  • Labelling & Packaging Compliance – Meeting UK-specific requirements.
    Liaison with MHRA – Managing regulatory communication for smooth approvals.

How to Appoint Eomi Consultancy as Your UKRP?

Step 1: Contact us for a free consultation.
Step 2: We assess your medical device classification & compliance status.
Step 3: Sign a UKRP agreement & submit required documentation.
Step 4: We complete MHRA registration & act as your official UKRP.
Step 5: Your medical devices are legally placed on the UK market.

Why Choose Eomi Consultancy as Your UKRP?

Complete Regulatory Support

Our seasoned consultants bring extensive expertise to guide you through the intricacies of UK medical device regulations. We ensure you stay informed of the latest regulatory changes, offering clear and practical advice to help you navigate the complex landscape with confidence and ease

Regulatory Documentation Review

Our team carefully reviews your technical documentation, including risk management files, labelling, and instructions for use, ensuring full compliance with UK regulatory standards. We identify any gaps or areas that may need improvement, providing you with the expertise needed to meet all requirements seamlessly.

Personalised Approach

We understand that every business is different. That’s why our team takes the time to get to know your specific needs, challenges, and objectives. We then tailor our services to deliver bespoke solutions that align perfectly with your goals, ensuring the best possible outcome for your business.

Collaborative Partnership

We prioritise building lasting relationships with our clients. By maintaining open communication and collaborating closely, we become an extension of your team. Our ongoing support and expert guidance help ensure you stay on track with regulatory compliance, every step of the way.