United Kingdom
Our expertise on U.K. market access will accelerate your time to market.
Accelerate your time to market
As a medical device or IVD manufacturer, you know that since Brexit, the U.K. has established its standalone regulatory framework for medical devices and IVDs – the UK Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) - requiring separate registration, conformity assessment, and compliance processes different from those in the EU. However, medical device and IVD manufacturers can still leverage their CE marking to place their devices on the UK market under transitional arrangements.
For non-UK manufacturers, appointing a UK Responsible Person (UKRP) is mandatory, adding further complexity.
We are the market leader for UKRP services. The UKRP plays a critical role in helping manufacturers navigate these changes by registering devices with the MHRA and acting as the official point of contact between your company and the MHRA for regulatory matters. We also provide PMS and vigilance support.
UK Responsible Person contracts
Discover how we can help:
Market Access U.K.
UKCA conformity processes to ensure a smooth and timely entry into the UK healthcare market.
U.K. Responsible Person
We guide you through MHRA registration.
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.
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.
Attempting to enter the U.K. market without dedicated local expertise can result in delayed registration, incomplete documentation, or incorrect labeling, each of which can lead to enforcement action or product withdrawal. Lack of clarity around post-Brexit regulations can cause strategic misalignment, rework, and unexpected costs.
Our proven track record, diverse expertise, and commitment to supporting manufacturers ensure that your devices meet UK regulatory standards without unnecessary delays. We simplify your journey to the U.K. market from strategic planning to compliance management.
Our team of regulatory experts helps you achieve seamless compliance and market access.
Couldn't find your question?
Is the CE mark still valid in the U.K.?
Currently, CE marking is accepted in Great Britain until the deadline set by MHRA (subject to extensions and updates). Still, UKCA marking will become mandatory for most devices in the coming years, though when depends on the medical device's risk classification.
What is a UK Responsible Person, and do I need one?
A UK Responsible Person is required for all non-UK manufacturers placing medical devices on the GB market; they act on your behalf with the MHRA and must ensure compliance with U.K. regulations.
What are the key steps to enter the U.K. market?
You must classify your device, register it with the MHRA, appoint a UK Responsible Person, and eventually comply with UKCA marking requirements.
Can you act as a regulatory consultant and a UK Responsible Person?
Yes. We provide end-to-end support: strategic regulatory guidance, technical file preparation, and legally mandated UK Responsible Person services under one roof.