UK Responsible Person

From 1 January 2021, the roles and responsibilitiesto place a device on the Great Britain market will change. Manufacturers based outside the UK will be required to appoint a UK Responsible Person that is established in the UK.

Manufacturers should appoint their UK Responsible Persons as soon as possible, where required. The UK Responsible Person will then need to register relevant devices with the MHRA in line with the grace periods depending on the device class:

Class III, Class IIb implantable devices, all active implantable medical devices and IVD List A products must be registered from 1 May 2021

Other Class IIb products, all Class IIa devices, IVD List B products and Self-Test IVDs must be registered from 1 September 2021

Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from 1 January 2022

The UK Responsible Person will act 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 will be set out in the UK MDR 2002 (in the form in which they exist 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.
• Provide the MHRA with all the information and documentation necessary to
• demonstrate the conformity of a device.
• Provide samples of a device to the MHRA or allow the MHRA 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 appointed.
• Inform the MHRA if the manufacturer acts contrary to its obligations under the
• applicable Regulations. Terminate the legal relationship with the manufacturer
• and inform to MHRA. If applicable, also inform to the relevant Notified Body of
• that termination.

From 1 January 2021, the name and address of the UK Responsible Person, where applicable, will need to be included on product labelling where the UKCA mark has been affixed. UK Responsible Person details will not need to be included on labelling for CE marked devices.