UK Responsible Person
When is a UK Rep required?
If your company is located outside Great Britain and you want to sell medical or in vitro diagnostic devices (IVDs) in England, Scotland, or Wales, appointing a UK Responsible Person (UK RP/UK Rep) is essential. A UK RP ensures your devices comply with UK regulations and is your liaison with the UK Health Authority and the Medicines & Healthcare Products Regulatory Agency (MHRA).
Since Brexit, medical device companies must meet additional regulatory requirements beyond the EU CE Marking to sell their devices in the UK. The UK RP plays a critical role in helping manufacturers navigate these changes by:
- Registering your devices with the MHRA.
- Ensuring your devices meet UK conformity requirements, including the UKCA marking, will become mandatory from July 2025.
- Acting as the official point of contact between your company and the MHRA for regulatory matters.
After the UK left the EU in early 2020, medical device companies now face additional certification and in-country representation requirements beyond EU CE Marking to market their devices in the UK.
The MHRA published its last update on July 28th, 2023, and intends to introduce legislation to bring into force the
transitional arrangements and post-market surveillance activities, as outlined in the government response on June 26th, 2022.
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Responsibilities of the UK Responsible Person
- Documentation Review
Verify the CE certificate (if applicable), the Declaration of Conformity (DoC), and technical documentation to ensure regulatory compliance.
- MHRA Registration
Register your medical devices and IVDs in the MHRA database per UK requirements.
- Communication with MHRA
Respond to all MHRA inquiries and provide necessary information and documentation to demonstrate device conformity.
- Samples and Device Access
Forward MHRA requests for samples or device access, ensuring timely delivery or arrangements for access.
- Risk Mitigation
Work with the MHRA to address and resolve risks associated with your devices. If elimination isn’t possible, implement measures to mitigate risks.
- Vigilance Communication
Support complaint handling and incident reporting from healthcare professionals, patients, and users. Ensure compliance with vigilance reporting requirements through the MORE portal.
- Record Maintenance
Maintain copies of technical documentation, the DoC, and relevant certificates (including amendments and supplements) for MHRA inspections.
Qserve’s UK RP Services
As your UK Responsible Person, Qserve will:
- Verify and manage documentation such as the CE certificate, DoC, and technical files.
- Act on your behalf with the MHRA to register devices and IVDs.
- Prepare a robust regulatory strategy for UKCA marking and contact Notified Bodies for technical file review when applicable.
- Ensure labeling conforms to UKCA standards.
- Support vigilance reporting through the MORE portal to ensure post-market surveillance compliance.
Qserve’s proven track record, diverse expertise, and commitment to supporting manufacturers ensure that your devices meet UK regulatory standards without unnecessary delays. Qserve simplifies your journey to the UK market from strategic planning to compliance management.
Let Qserve’s team of regulatory experts help you achieve seamless compliance and market access.
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