UK Responsible Person | Joe Hagan-Brown

Since the UK left the EU, under the amended UK Medical Device regulations 2002, manufacturers based outside of the UK are required to appoints a UK Responsible Person, based within the UK, in order to place a device on the Great Britain market. The UK responsible person, essentially is the main contact point between the UK competent authority: the MHRA and the manufacturer. The person appointed to this role also is legally responsible for fulfilling a number of obligations of the manufacturer. These obligations are set out within the amended UK Medical Device Regulations 2002. These obligations include:

  • Checking the correctness and legality of the Declaration of conformity and technical documentation of the manufacturer
  • Maintaining certain technical, and regulatory documentation of the manufacturer and ensuring they remain available for inspection by the Competent authority
  • Providing the MHRA with any requested information, to demonstrate the conformity of a device
  • Ensuring and permitting the MHRA access to any retained samples of a device
  • Immediately informing the manufacturer of any complaints and or reports from end users patients or other consumers of the device of any potential. Suspected incidents involving the device
  • Being identifiable on product labelling and packaging of the device as the UK responsible person of the manufacturer.
  • Registering the medical devices with the MHRA.

For non-UK based manufacturers of medical devices its important that there are current, and functional procedures documented and in place within their organisation to ensure these responsibilities of the UK Responsible person are assigned to an individual with the necessary competence. The UK regulations, unlike the EU MDR 2017/745 do not clearly define the level of competence the UK Responsible person is expected to have. This is left to the manufacturer’s discretion. Nevertheless in our opinion it is reasonable to expect that the UK Responsible person should have quality, and regulatory experience in the field of medical devices, and should have also worked within medical device manufacturing for some time. An academic qualification in a scientific or technical discipline would also be appropriate.

Non-UK-Based manufacturers are required by UK law to appoint a UK Responsible person in order to place medical devices onto the GB market. Its important that the manufacturer appoints a UK responsible person which provides a service which is transparent, responsive and reliable:

Responsive: Prompt replies to regulatory authorities, and a 24hr manned UKRP mailbox

Reliable: The UK Responsible person needs to have in house competence to fulfil their regulatory and legal obligations

Transparent: The Person or organisation appointed needs to be able to provide regular updates on the activities being conducted to fulfil the UKRP obligations.

Find out more about the UK Responsible Person services MedRAS can provide your organisation here