FAQ

What is a UK Responsible Person?

A UKRP acts on behalf of non‑UK manufacturers to ensure their medical devices meet UK regulatory requirements.

Do I need a UKRP?

Any manufacturer outside the UK placing devices on the Great Britain market must appoint a UKRP.

What types of devices do you support?

We work with Class I, IIa, IIb, III, implantable, digital, and AI‑enabled devices.

Do you offer NHS procurement support?

Yes. We help manufacturers understand NHS purchasing pathways, frameworks, and adoption processes.

What is an Equity Review?

A structured assessment of how a device performs across different demographic groups, aligned with the UK’s Equity in Medical Devices Review.

What are your fees?

Pricing varies depending on the service you select and the level of support required. Please contact us to discuss your needs and receive a tailored proposal.