The United Kingdom’s (UK’s) Medicines and Healthcare products Regulatory Agency (MHRA) have added a new section to their “no-deal Brexit” guidance for medical devices, regarding the “UK Responsible Person”.
The UK Responsible Person will be a new role created under the Medical Devices Regulation 2019 (UK MDR), in the instance of a no-deal Brexit. They will be either an individual or a company established in the UK, who acts on behalf of a non-UK manufacturer established outside the UK, in relation to specified tasks with regard to the manufacturer’s obligations under these regulations. If a company is designated as the UK Responsible Person, the responsibilities of the role would fall on the company as a whole.
The key tasks and responsibilities of this role will include registering with the MHRA before a device is placed on the UK market. Furthermore, if requested, they will have to provide all the necessary documentation to demonstrate device conformity. The person must also coordinate any requests between the MHRA and the manufacturer and “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 designated.” A full list of the responsibilities are set out in Part II (r. 7A), Part III (r. 21A) and Part IV (r. 33A) and in new Parts VIII and IX in regulation 77 (for medical devices) and regulation 146 (for in-vitro diagnostic devices (IVDs)) of the UK MDR 2002 (as amended by the UK MDR 2019).
There will be a grace period for manufacturers to have in place a UK Responsible Person, which will be in line with the grace period for registering their particular device with the MHRA. We recommend that manufacturers appoint a UK Responsible Person before the end of the grace period as they may need time to create a mandate.
To view the full updated guidance on this new role, click here.
To find out more information on relevant grace periods, click here.