UK Device Registration Service

UK Responsible Person (UKRP)

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

Definition: UK = Great Britain + Northern Ireland, Great Britain = England + Wales + Scotland

Register Medical Devices

As of 1st January 2021, it is a UK government requirement that all medical devices placed on the Great Britain market are registered with the MHRA. Under the terms of the Northern Ireland Protocol, the rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain; however, there is a requirement, in most cases, to register these devices with the MHRA.

For full details concerning these requirements see the UK government website by clicking here 

Applicable Regulations

Great Britain: In Great Britain, devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA.

Northern Ireland: Unlike in Great Britain, the EU Medical Device Regulations (2017/745) and the in vitro Diagnostic Medical Device Regulations (2017/746) will apply in Northern Ireland from 26 May 2021, and 26 May 2022 respectively, in line with the EU’s implementation timeline.

Who completes the Device Registration

Great Britain: Manufacturers based outside the UK must appoint a single UK Responsible Person who will take responsibility for their product in Great Britain.

Northern Ireland: Manufacturers based outside the UK wishing to place a device on the Northern Ireland market must appoint a UK Responsible Person to register their devices, however if the manufacturer’s EU Authorised Representative is based in Northern Ireland, then the Authorised Representative is allowed to perform registration.

Importers

In cases where the Great Britain importer is not the UK Responsible Person, the importer must inform the relevant UK Responsible Person of their intention to import a device. The UKRP is then required to register the importer with the MHRA.

Role of the UK Responsible Person

The UK Responsible Person acts on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. The responsibilities of the UK Responsible Person are set out in the UK MDR 2002 (as amended). In summary, in addition to the above registration requirements the UK Responsible Person must:

• 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.
• Where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device.
• Where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request.
• 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 appointed.
• If the manufacturer acts contrary to its obligations under these Regulations:
• Terminate the legal relationship with the manufacturer; and
• Inform the MHRA and, if applicable, the relevant Approved Body of that termination.

The name and address of the UK Responsible Person, where applicable, must be included on product labelling where the UKCA mark has been affixed. UK Responsible Person details do not need to be included on labelling for CE marked devices.