Responsible Person service for non-UK medical device manufacturers placing devices on the UK market.
Manufacturers based outside the UK must appoint a UK Responsible Person to register devices with the MHRA and act as their UK regulatory contact.
We act as your UK Responsible Person, handling registration and ongoing regulatory liaison.
Non-UK medical device manufacturers placing devices on the UK market.
The regulatory step required before you can sell in this market.
Well-prepared submissions face fewer rounds of questions.
Get the classification and documentation right the first time.
We know what this specific regulator actually expects.
We stay engaged as requirements evolve, not just at submission.
A cleared regulatory pathway makes partners more comfortable.
The same straightforward path applies across every standard and service we support.
Gap review & scoping
Build required documentation
Assessment / submission
Certificate / clearance issued
Tell us a bit about your organization and we'll put together a straightforward, competitive quote.