UK Responsible Person - Medical Devices
If your company is based outside the UK and places medical devices on the Great Britain market, you must appoint a UK Responsible Person. MEDAGENT International UK Limited acts as your local regulatory contact, supports MHRA registration and keeps the required documentation available for the authority.
What is a UK Responsible Person?
A UK Responsible Person is a UK-based person or company authorised in writing to act for a non-UK manufacturer. The role covers specified manufacturer obligations under the UK Medical Devices Regulations 2002, including registering devices with the Medicines and Healthcare products Regulatory Agency before they are placed on the Great Britain market.
Great Britain means England, Scotland and Wales. Northern Ireland follows a different regulatory route, so your exact market plan should be confirmed before registration.
What MEDAGENT handles
- Act as your designated UK Responsible Person through MEDAGENT International UK Limited.
- Register your organisation and applicable devices with the MHRA.
- Check the Declaration of Conformity, technical documentation and ensure relevant certificates are available.
- Keep required copies accessible for MHRA inspection.
- Coordinate authority questions and information requests with your team.
Support updates when products, certificates, importers or registration information change.
Why manufacturers choose MEDAGENT
MEDAGENT created a dedicated UK entity to carry out the UK Responsible Person role with a local structure and direct regulatory focus. The process is built around prepared templates, document review and guided submission, helping international teams organise a requirement that can otherwise feel fragmented.
You also gain access to wider MEDAGENT expertise across quality management, international registration and representative services if the UK is one part of a larger expansion plan.
Frequently Asked Questions
Who must appoint a UK Responsible Person?
Manufacturers based outside the UK must appoint a UK Responsible Person when placing medical devices on the Great Britain market.
Is a UK Responsible Person the same as an EU Authorised Representative?
No. They are separate roles under different regulatory frameworks. A company selling in both Great Britain and the EU may need both.
What documents must be available?
The role includes checking and keeping available the Declaration of Conformity, technical documentation and relevant certificates, along with other information required for registration or authority review.
Does MEDAGENT support ongoing changes after registration?
Yes. MEDAGENT can support updates and continued authority communication after the initial registration. The precise scope should be set out in the service agreement.
Stay Updated on Regulatory Changes
We publish monthly newsletters that summarise changes in medical device regulations on our LinkedIn Newsletter.
Click below to visit our LinkedIn Page, follow us to stay updated on our services, updates in the industry, and special offers.
