Understanding the Role of the UK Responsible Person (UKRP) Under MHRA Regulations: How AF Pharma Can Help
The United Kingdom’s departure from the European Union has brought significant regulatory changes for medical device manufacturers. One of the most critical adjustments is the requirement for non-UK manufacturers to appoint a UK Responsible Person (UKRP) to place their medical devices on the UK market. This blog delves into the UKRP’s role under the UK Medical Device Regulations 2002 (as amended), outlines its responsibilities, and highlights how AF Pharma can support your compliance needs.
What is a UK Responsible Person (UKRP)?
The UKRP is a legal entity or individual based in the UK, designated by a non-UK manufacturer to act on their behalf for compliance with the UK Medical Device Regulations. The role ensures that devices meet the necessary requirements before being placed on the UK market.
Key Responsibilities of the UKRP
1. Device Registration with MHRA
The UKRP is responsible for registering the manufacturer’s devices with the Medicines and Healthcare products Regulatory Agency (MHRA). This includes:
Ensuring all necessary documentation is submitted.
Keeping the MHRA updated about device changes or discontinuations.
2. Conformity and Documentation Review
The UKRP must:
Verify that the manufacturer has completed the appropriate conformity assessments.
Ensure the technical documentation is complete and aligns with UK regulatory requirements.
3. Labeling and Packaging Compliance
The UKRP ensures the device labeling includes:
The UKRP’s name and address.
Necessary symbols and information in English to comply with UK requirements.
4. Post-Market Surveillance (PMS)
The UKRP works with the manufacturer to oversee PMS activities, ensuring the device remains compliant and performs safely in the market.
5. Vigilance and Incident Reporting
The UKRP handles communication with the MHRA regarding:
Serious incidents.
Field safety corrective actions (FSCAs).
6. Retention of Documentation
The UKRP must keep copies of the declaration of conformity, technical documentation, and other relevant records for inspection by the MHRA.
Who Needs a UKRP?
All non-UK manufacturers placing medical devices, in vitro diagnostic devices (IVDs), or custom-made devices on the UK market must appoint a UKRP. This includes:
Devices bearing a CE mark under EU regulations (temporary acceptance until the transition to UKCA marking).
Devices requiring UKCA marking post-transition.
UKRP and UKCA Marking Transition
As of July 1, 2025, the UK will require most medical devices to carry the UK Conformity Assessed (UKCA)Â mark instead of the CE mark. The UKRP plays a critical role in this transition, ensuring devices meet UKCA requirements and facilitating smooth market access.
Challenges for Manufacturers
1. Regulatory Differences
Understanding the nuances between EU MDR/IVDR and UK Medical Device Regulations can be challenging, especially during the transition to UKCA marking.
2. Ongoing Obligations
The UKRP’s responsibilities don’t end with device registration—they extend to PMS, vigilance, and regulatory updates, requiring ongoing effort and expertise.
3. Reputation and Trust
The UKRP acts as the manufacturer's legal representative in the UK, so choosing a trustworthy and experienced partner is crucial to maintaining compliance and market credibility.
How AF Pharma Can Support You as Your UKRP
AF Pharma, with its proven track record in regulatory compliance, offers comprehensive UKRP services to non-UK manufacturers. Here’s how we can help:
1. Device Registration with MHRA
We handle all aspects of device registration, ensuring timely and accurate submissions to the MHRA for seamless market entry.
2. Technical Documentation and Compliance
Our experts review and maintain your technical documentation, ensuring it aligns with UK regulatory requirements.
3. Labeling and Packaging Support
We guide you in updating device labels to include the UKRP’s details, meeting MHRA requirements and avoiding market disruptions.
4. Vigilance and PMS Management
AF Pharma oversees PMS and incident reporting activities, acting as your direct liaison with the MHRA for regulatory communication.
5. Transition to UKCA Marking
We provide end-to-end support for the transition from CE marking to UKCA marking, helping you navigate the evolving regulatory landscape.
6. Local Expertise
As your UKRP, we ensure that your devices are always compliant with UK-specific regulations, minimizing risks and delays.
Why Choose AF Pharma as Your UKRP?
AF Pharma is committed to ensuring smooth regulatory compliance for medical device manufacturers. With extensive experience in both EU and UK regulatory frameworks, we provide reliable UKRP services that keep your devices market-ready.
Benefits of AF Pharma:
Experienced regulatory specialists.
Comprehensive support for MHRA communication and device registration.
Expertise in PMS, vigilance, and UKCA marking transition.
Trusted partner for maintaining compliance and market trust.
Secure Your UK Market Presence
The UKRP is essential for non-UK manufacturers to access the UK medical device market. By partnering with AF Pharma, you can ensure seamless compliance with MHRA regulations and focus on delivering high-quality medical devices.
Ready to expand your market reach? Contact AF Pharma Services today to learn more about our UKRP services and how we can help you navigate the UK regulatory landscape with confidence!
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