UK Responsible Person requirements for medical device firms
A UK Responsible Person acts for non-UK medical device manufacturers supplying Great Britain. Appointment, registration and labelling duties follow.
A UK Responsible Person (UKRP) is a person established in the UK who acts for a manufacturer established outside the UK on specified tasks. Manufacturers in that position must appoint one UKRP before placing a device on the Great Britain market (England, Wales and Scotland). The role covers regulatory duties and MHRA registration, not just a contact address. UK definition, MHRA appointment guidance.
Who needs a UK Responsible Person?
A manufacturer based outside the UK needs a UKRP to supply Great Britain. Northern Ireland is part of the UK, so being based outside Great Britain alone does not trigger this requirement. MHRA guidance.
MHRA says that manufacturer must appoint a single UKRP for all of its medical devices. Do not divide that manufacturer's device ranges between different UKRPs. The representative assumes the manufacturer's device-registration responsibilities, and devices must be registered before placement on the GB market. MHRA registration guidance.
An importer or distributor can also act as the UKRP. But importing or distributing devices doesn't appoint that business. The UKRP still has to be established in the UK, and it needs the manufacturer's written authority for the role. MHRA UKRP guidance.
What must the UKRP do?
Registration is only one part of the UK Responsible Person requirements. The UKRP must:
- Ensure the declaration of conformity and technical documentation have been drawn up. Where applicable, ensure the manufacturer has performed the appropriate conformity assessment.
- Keep copies of the technical documentation, the declaration of conformity and relevant certificates, including amendments and supplements, available for MHRA inspection.
- Provide information and documents demonstrating conformity when MHRA requests them.
- Where the UKRP has samples of the device or access to it, comply with an MHRA request for those samples or that access. Where it has neither, pass MHRA's request to the manufacturer and tell MHRA whether the manufacturer intends to comply.
- Cooperate with MHRA on preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which the UKRP has been appointed.
- If the manufacturer acts contrary to its obligations under the Medical Devices Regulations 2002, terminate the legal relationship. Inform MHRA and, where applicable, the relevant approved body.
These are MHRA's stated UKRP duties. The samples duty does not require every UKRP to hold physical stock.
Appointing a UKRP and preparing the agreement
MHRA requires written evidence that the manufacturer has authorised the UKRP. The letter of designation is a legal contract. It must state that the appointee is the exclusive UK Responsible Person acting for the manufacturer, and it must specify the mandatory tasks that person is contracted to undertake. Appointment guidance, designation-letter requirements.
If you start from a UK Responsible Person agreement template, the letter still has to do those two things. A document that only gives a UK contact address is not an appointment. Match the draft to the current MHRA registration guidance.
MHRA UK Responsible Person registration
The UKRP provides each represented manufacturer's details and registers that manufacturer's devices through MHRA's Device Online Registration System, DORS. Required manufacturer information includes the legal entity name and address as it appears on the device labelling or packaging, the company type, an administrative contact and, where applicable, the letter of designation. MHRA registration guidance.
Creating a DORS account is not device registration. MHRA does not regard a device as registered until the device details have been provided and confirmation of registration has been received. Do not place the device on the GB market on the strength of an account alone. Current registration guidance.
DORS accounts of former Great Britain-based authorised representatives that had not been updated to UK Responsible Person by 30 March 2026 are now closed. Do not use that superseded role. MHRA registration guidance.
To find a UKRP's details, start with the manufacturer record. MHRA says the UK Responsible Person's name and address are displayed within that record, where applicable. PARD, the Public Access Registration Database, cannot currently be searched by representative. Registration is not MHRA accreditation, certification, approval or endorsement. MHRA public-register guidance.
A change of UK Responsible Person requires a new registration. Read the registration guidance before you submit it.
Where UKCA responsible person details must appear
For a device with UKCA marking, the UK Responsible Person's name and address must appear on the product labelling, the outer packaging or the instructions for use. The same applies when the device carries both the CE and UKCA marks. The details do not have to be printed on the device itself. MHRA labelling guidance.
MHRA says UKRP details do not need to appear on labelling for a CE-marked device, unless that device also bears the UKCA mark. That labelling relief doesn't remove the appointment or GB registration duty for a manufacturer based outside the UK. MHRA guidance.
Does a UKRP cover Northern Ireland?
A UKRP appointment is not EU or Northern Ireland authorised representation. EU MDR and IVDR rules apply in Northern Ireland. A manufacturer outside Northern Ireland and the EU must appoint an authorised representative based in the EU or Northern Ireland in order to place a device on that market. Treat that supply as a separate appointment. MHRA jurisdiction guidance, NI registration guidance.
RegAffairs AI's answer on UK Responsible Person duties and registration links to the regulatory sources behind the role.