UK Responsible Person (UKRP)

for Medical Devices and In Vitro Diagnostic Devices

The UK Responsible Person (UKRP) is required by the UK Authorities for Medical Devices & In Vitro Diagnostic Medical Devices Manufacturers located outside the UK. In order to place medical devices in the UK market, you need to appoint a UKRP according to the Medical Devices Regulations 2002.

The UK Responsible Person acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. ... this includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.

UK Responsible Person (UKRP) tasks:

Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.
Cooperate with the MHRA on any 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 they have been designated.
Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.

Source: Regulating medical devices from 1 January 2021

Contact MDSS now

MDSS is ready to support Medical Device Manufacturers located outside the UK.

Our experienced team of Regulatory Affairs experts will guide you through the requirements of the MHRA (Medicines and Healthcare products Regulatory Agency).

MDSS-UK RP Ltd. is your UK Responsible Person

We can apply for a Free Sales Certificate (FSC) in the UK on your behalf!

** From MHRA: ... to place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person. The UK Responsible Person must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person.