UK Responsible Person — MHRA registration via our Oxford office
A UK Responsible Person (UK RP) is the UK-established legal entity required for non-UK manufacturers placing medical devices on the GB market — registered with the MHRA under UK MDR 2002. Since 1 January 2021, every medical device and IVD on the UK market must have a designated UK RP. We've held that role from our Oxford office since the same January — operational from day one of the post-Brexit regime, for manufacturers from across the EU, Asia and the United States.
UKRP duties we cover
Same scope as the European Authorised Representative role, mirrored for the UK market. If you mandate us for both, the same team manages your MHRA file and your EUDAMED submissions — one contract, one contact, two markets.
Documentation verification
Verification of technical documentation against UK MDR 2002 requirements and notified-body certification.
MHRA registration
Registration of medical devices and IVDs with the MHRA on behalf of non-UK manufacturers.
Vigilance
UK-market vigilance reporting and incident liaison between manufacturer and the MHRA.
MHRA liaison
Direct liaison with the MHRA as your Responsible Person on the UK market.
After mandate signing and document review, MHRA registration is typically initiated within a few business days. The main variable is MHRA processing time on their side — not our internal turnaround.
Your questions about UK representation
After Brexit, manufacturers based outside the United Kingdom who place medical devices on the GB market must designate a UK Responsible Person to register devices with MHRA and act as the manufacturer’s UK regulatory counterpart.
Any manufacturer outside the United Kingdom who sells medical devices or IVDs into Great Britain (England, Scotland, Wales). Northern Ireland follows EU regulations and uses an EU Authorised Representative.
Register the manufacturer and devices with MHRA, keep technical documentation available for inspection, cooperate on vigilance and incident reporting, and terminate the appointment if the manufacturer becomes non-compliant.
Yes. UK Medical Devices Regulations 2002 (as amended) cover medical devices, active implantable devices, and in-vitro diagnostics — all under our single UKRP service.
Yes. MT Promedt acts as both EU Authorised Representative (Germany, EUDAMED SRN: DE-AR-000000085) and UK Responsible Person via our Oxford office — one mandate, two markets.
After mandate signing and document review, MHRA registration is typically initiated within a few business days. The MHRA processing time is the main variable.
Download our UK Responsible Person brochure
Service brochure
UK Responsible Person — English
UK Responsible Person — German
Need a UK Responsible Person?
Get a tailored UKRP quote within 24 hours and start your MHRA registration with a partner present in Oxford since January 2021.