UK Responsible Person

As noted above, 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. UK Responsible Person requirements for the Northern Ireland market are covered separately below. Importers and distributors are not required to appoint a UK Responsible Person.

Please note that the accounts of any former Great Britain-based Authorised Representatives that have not updated their role to UK Responsible Person on the MHRA registration system, as well as the accounts of any represented manufacturers, will be suspended from 1 January 2022 until the relevant UK Responsible Person has updated their role. For further information on registration requirements, please see guidance on registering medical devices.

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

The responsibilities of the UK Responsible Person are set out in the UK MDR 2002. 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 
  • terminate the legal relationship with the manufacturer; and
  • inform the MHRA and, if applicable, the relevant Approved Body of that termination.

There is nothing to prevent an importer or distributor from also acting as a UK Responsible Person.

The name and address of the UK Responsible Person, where applicable, must be included on the product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed. UK Responsible Person details do not need to be included on labelling for CE marked devices, unless the device bears both the CE and UKCA markings.

Importers and distributors:

In cases where the Great Britain importer is not the UK Responsible Person, the importer is required to inform the relevant manufacturer or UK Responsible Person of their intention to import a device. In such cases, the manufacturer or the manufacturer’s UK Responsible Person is required to provide the MHRA with details of device importers. Further guidance on device registrations.

Obligations around storage, transportation and checking device labels for the CE marking or UKCA marking also apply. The importer or distributor’s name and address do not need to be present on the label unless the importer or distributor are acting as the UK Responsible Person for the purposes of the UKCA marking.

UK Responsible Person:

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