UK Responsible Person (UKRP) service for medical device manufacturers
Selling medical devices in Great Britain from outside the UK? You need a UK Responsible Person. OscarTech UK already acts as UKRP for manufacturers and knows the MHRA registration process.
Why manufacturers choose us
- Already UKRP for a number of manufacturers
- UK-based, NHS Supply Chain approved supplier
- We understand MHRA registration end to end
- ISO 9001 certified and Cyber Essentials certified
The legal link between you and the MHRA
A manufacturer based outside the UK must appoint a UK Responsible Person before its devices can be placed on the Great Britain market. The MHRA only accepts device registrations from UK-based manufacturers, so your UKRP registers your devices on your behalf and answers to the MHRA for them.
Do you need one?
Yes if you make medical devices outside the UK and sell them in Great Britain, whether they carry a CE mark or a UKCA mark.
No if you are an importer or distributor in the UK. You do not need to appoint one, although you can act as one.
The UKRP duties, handled for you
Following the MHRA's requirements, we take care of the UK side of your compliance.
Document check
We check your declaration of conformity and technical documentation are in place before you go to market.
MHRA registration
We register your devices with the MHRA on your behalf.
Documents on file
We keep your documents available for MHRA inspection and respond to MHRA requests.
Corrective actions
We cooperate with the MHRA on corrective actions and keep you informed.
Complaints and incidents
We pass complaints and incident reports from the UK on to you.
Labelling check
Where the UKCA mark is applied, we check our name and address appear on the label, packaging or instructions for use.
From enquiry to registered devices
Every manufacturer's devices are different, so we start with a short conversation.
Tell us about your devices
Fill in a short form: what you make, the risk class and how the devices are marked today.
Get your quote
We review your devices and send you a quote and a list of what we need from you.
Agree and register
We agree the arrangement in writing and register your devices with the MHRA.
Ongoing support
We carry out the UKRP duties and keep you updated on changes to UK requirements.
Experience you can check
UKRP FAQs
What is a UK Responsible Person?
A UK-based person that a non-UK manufacturer appoints to act for its devices on the Great Britain market. They register the devices with the MHRA and carry out set duties on the manufacturer's behalf.
Do I need a UKRP if my devices are CE marked?
Yes. If you are based outside the UK and place devices on the Great Britain market, you need a UKRP whether the devices carry a CE mark or a UKCA mark.
Does a UK importer or distributor need a UKRP?
No. The duty falls on manufacturers based outside the UK. Importers and distributors do not need to appoint one, though they can act as one.
What about Northern Ireland?
Northern Ireland follows different rules. CE marking is required, and a Great Britain-based manufacturer needs an EU or Northern Ireland-based authorised representative. Ask us and we will explain what applies to your devices.
How much does the UKRP service cost?
The cost depends on your devices, their risk class and how many you have. Tell us about them and we will send you a quote.
Can I switch from my current UKRP?
Yes. Choose "Changing from another UK Responsible Person" on the quote form and we will explain how the change works.
Ready for a UKRP quote?
Tell us about your devices. It takes a couple of minutes and there is no obligation.