The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its no-deal Brexit guidance, advising medtech businesses outside the UK to designate a ‘UK Responsible Person’ to ensure medical devices remain on the market in the event of a no-deal Brexit.
The UK is currently scheduled to leave the EU on 31 October, and has yet to agree on a deal defining its future relationship with Europe.
The UK Responsible Person role was roughly outlined in guidance published in February, but the MHRA has now added to the description of the role.
Manufacturers based outside the UK would need to select a UK Responsible Person tasked with acting on behalf of the manufacturer in supplying devices to the British market after Brexit. This can be either an individual or a company, and should be physically based in the UK at all times.
An MHRA spokesperson said: “The role can either be designated to an external individual or company, or they can be part of the same organisation as the legal manufacturer. In either case a mandate must be drawn up between the UK Responsible Person and the legal manufacturer.”
The UK Responsible Person would need to be in place by the end of the grace period for registering devices, which ranges between four and 12 months depending on the nature of the product. This individual or group would then need to open a registration on behalf of the manufacturer they represent.
The UK Responsible Person is also expected to ensure all documentation and technical declarations are in place, and that appropriate conformity assessment has been carried out by the manufacturer. They would also coordinate any requests between the MHRA and the manufacturer, such as information about adverse incidents relating to devices.
In the event of a deal between the UK and the EU, the need to establish a UK Responsible Person would be eliminated, but there are major doubts as to whether this will be possible. EU chiefs have declared that the possibility no-deal is “palpable”, and have criticised UK Prime Minister Boris Johnson for “pretending to negotiate” after refusing to hand out written proposals regarding the contentious issue of the post-Brexit Irish border.