UK Responsible Person Services
UK Responsible Person Services
If you are a medical device manufacturer based outside the UK, you must appoint a MHRA UK Responsible Person (UKRP) if you intend to place your devices on the UK market. The UKRP plays a vital role in ensuring that your devices comply with all relevant UK regulations and standards.
Do you need UKRP services?
UK Responsible Person (UKRP)
- An IVD and/or MD manufacturer
- Based outside the UK
- Planning to sell your products in the UK
If you answered “yes” to any of these questions, you will need the services of a UK Responsible Person.
Authorised Representative
- An IVD and/or MD manufacturer
- Located in the UK or outside the EU
- Sell your products in the EU
If so, you will need an Authorised Representative.
Responsibilities of a UKRP:
The UKRP has a number of responsibilities, including
Registering your devices with the Medicines and Healthcare products Regulatory Agency (MHRA)
Maintaining the technical documentation for your devices
Ensuring that your devices are manufactured in accordance with applicable regulations and standards
Investigating and reporting any adverse incidents involving your devices
Respond to MHRA requests for further information or documentation
How we can help:
UKRP appointment
Device registration with the MHRA
Technical Documentation Review and Maintenance
Quality Management System review and implementation
Adverse event reporting and investigation
MHRA liaison
Our team consists of experienced and qualified UKRP professionals who can guide you through all aspects of UKRP compliance. We are proud members of the UK Responsible Person Association (UKRPA), a trade association for UKRP providers.
We have a thorough understanding of the UK regulatory landscape and can keep you informed of the latest changes.
We offer a personalised service, tailoring a UKRP compliance plan to meet your specific needs.
We are committed to providing a high level of service and support.
Find out more about our UKRP services and how we can help you place your medical devices on the UK market.
