10. UK Responsible Persons (UKRPs) – Roles and responsibilities

Last Updated on 23/08/2023 by Sarah Sarsby

The Role of the UK Responsible Person (UKRP): See this guidance for the roles and responsibilities of a UKRP, which could form the basis of a contract between a manufacturer and a UKRP; in summary, a UKRP 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/supplements for MHRA inspection
• In response to a request from the MHRA, provide conformity information and documentation
• 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
• Cooperate with the MHRA on any preventive or corrective action taken to mitigate/eliminate device risks
• 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 UK Regulations:
  • Terminate the legal relationship with the manufacturer; and
  • Inform the MHRA and, if applicable, the relevant Approved Body of that termination
  • Note: UKRP name and address must be included on the product labelling in the case where a UKCA mark is applied.

UK Responsible Person Association (UKRPA): The UKRPA is an alliance of providers of UKRP services.  If you wish to find a professional UKRP, the email addresses of members can be found on the UKRP Members page.

European Association of Authorised Representatives (EAAR): The EAAR is an alliance of providers of EU Authorised Representative (EUAR) services. When placing devices on the EU or Northern Ireland markets, manufacturers from GB or other countries outside the EU must appoint either an EU-based or NI-based authorised representative[1]. If you wish to find a professional EUAR, the email addresses of members can be found on the EAAR Members page.

[1] NB, there are some companies that provide both UKRP and EUAR services; in instances where these companies have a registered office in Northern Ireland, it is possible that a UKRP and EU authorised representative could be the same entity.