After Brexit in order 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 that is established in the UK. Requirements for appointing a UK Responsible Person to place devices on the Northern Ireland market are covered separately below. Importers and distributors are not required to appoint a UK Responsible Person.
Manufacturers should aim to appoint their UK Responsible Persons as soon as possible, where required. The UK Responsible Person must then register relevant devices with the MHRA in line with the above grace periods depending on the device class.
The UK Responsible Person acts on behalf of the outside-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.
The responsibilities of the UK Responsible Person are set out in the UK MDR 2002 (in the form in which they existed on 1 January 2021). 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.
It is possible for an importer or distributor to act as a UK Responsible Person.
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.
