UK Responsible Person Services

At LFH Regulatory, we offer comprehensive UKRP services to help make sure you are compliant with UK MDR 2002 prior to entering the UK market but also registering your devices with the Medicines and Healthcare products Regulatory Agency (MHRA).

Are you ready to access the UK Market?

Our UK Responsible Person Service

Appointing a UK Responsible Person: We serve as your trusted UK Responsible Person, representing your business in compliance with the UK MDR regulation.

The UK Responsible Person (UKRP) service offered by the team here at LFH Regulatory ensures that your medical devices meet the regulatory requirements of the UK Medical Devices Regulations 2002 (UK MDR 2002). This regulation governs the safety and performance of medical devices so it’s paramount that you meet the requirements it outlines. By appointing LFH Regulatory as your UKRP, you can take the complications out of compliance.

We are committed to staying ahead of regulatory changes, including the upcoming amendments to UK MDR. We are prepared to respond swiftly and effectively to these changes.

Are you ready to access the UK Market?

Why Choose LFH Regulatory for UK Responsible Person Services?

Comprehensive Regulatory Guidance:

Our experienced consultants provide in-depth knowledge and guidance on the UK regulatory requirements for medical devices. We keep you updated with the latest changes and assist you in navigating the complex regulatory landscape with ease.

Regulatory Documentation Review:

Our team conducts thorough reviews of your technical documentation, including risk management files, labelling, and instructions for use. We ensure compliance with UK regulatory standards, identifying any gaps or areas for improvement.

Personalised Approach:

We recognise that every business is unique. Our team takes the time to understand your specific needs, challenges, and goals, tailoring our services to provide customised solutions that align with your requirements.

Collaborative Partnership:

We believe in fostering strong relationships with our clients. Through open communication and collaboration, we function as an extension of your team, offering ongoing support and guidance to help you achieve regulatory compliance.

Are you ready to access the UK Market?

Frequently Asked Questions

As a UK Responsible Person, our role includes ensuring that your medical devices meet the regulatory requirements established by UK competent authority. We act as a point of contact for regulatory authorities. As your UKRP we would be responsible for:

  • Managing your device registrations with the Medicines & Healthcare Regulatory Agency (MHRA). 
  • Ensuring that your declaration of conformity and technical documentation has been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer. 
  • Keep available a copy of your technical documentation, a copy of the declaration of conformity, and, if applicable, a copy of the relevant certificate, including any amendments and supplements, for inspection by the MHRA. 
  • Responding to requests from the MHRA and providing them with all the information and documentation necessary to demonstrate the conformity of a device. 
  • Provide samples of your device to the MHRA or allow them access to the device where the UK Responsible Person has samples. Where they do not have access or samples, forward to the manufacturer any request from the MHRA for samples or access. 
  • Co-operate with the MHRA on any preventive or corrective action taken to eliminate risks or mitigate risks posed by the device. 
  • Immediately inform you about complaints and reports from healthcare professionals, patients and users about suspected incidents related to your device for which they have been designated. 
  • Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these regulations and inform the MHRA and, if applicable, the relevant Approved body of that termination. 

To learn more, you can read our blog here

Appointing a UK Responsible Person is a regulatory requirement for manufacturers based outside the UK who intend to place medical devices on the UK market. Having a dedicated UKRP ensures compliance with UK regulations and facilitates market access, allowing you to reach a broader customer base.

Simplify your UK regulatory obligations and access the UK market confidently with LFH Regulatory as your trusted UK Responsible Person. Our team of experts is ready to assist you in achieving regulatory compliance, enabling you to focus on your core business activities.

Contact us today to discuss your UKRP requirements and alleviate the stress associated with UK Regulation.

Additional Services

As a full-service Medical Device Compliancy Company, we offer a suite of additional services:

Expertise and Experience

Our consultants possess extensive knowledge of UK regulatory requirements and are well-versed in the intricacies of the medical device industry. With our expertise, we guide you through the compliance process, reducing risk and ensuring successful market access.

Regulatory Strategy Development:

We collaborate closely with you to develop a tailored regulatory strategy that aligns with your business goals. Our experts assess your device portfolio, identify regulatory requirements, and assist in implementing strategies for successful market access.

Get Your FREE UKRP Checklist

Get your FREE UKRP Compliance Checklist.

Complied by the experts at LFH Regulatory this list will help you review your current documentation and if you’re ready to access the UK Market.