Dive Brief:

• The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) provided further advice Wednesday on the 'UK Responsible Person' role it has created to enable companies to place devices on the market in the event of a no-deal Brexit. 

• In an update published Wednesday to its no-deal guidance, the regulator clarified who can be a UK Responsible Person and what responsibilities they will have.

• The update comes against a backdrop of rising concerns that the U.K. will leave the European Union without a deal.

Dive Insight:

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) first published its 'Regulating medical devices in the event of a no-deal Brexit' guidance around one month before the original date of the planned split from the EU. A subsequent extension pushed back the date of the U.K.’s departure from the EU to the end of October.

MHRA has used the extra time to provide additional advice about the UK Responsible Person role that was created in legislation earlier this year. The February guidance provided an overview of the role, which serves as a link between ex-U.K. companies and MHRA, but was light on details.

The latest update fleshes out MHRA’s thinking. Manufacturers based outside the U.K. will need a UK Responsible Person to place devices on the market after Brexit. The UK Responsible Person can be either an individual or a company and does not need “any specific requirements for qualifications or knowledge.” There must be someone physically based in the U.K. at all times, however. 

Manufacturers will need to have a UK Responsible Person in place by the end of the grace period for registering devices, which runs for four to 12 months, depending on the nature of the product. That deadline reflects the responsibilities of the UK Responsible Person. 

The UK Responsible Person will need to open a registration account on behalf of their manufacturer and use it to register devices. MHRA also expects the UK Responsible Person to ensure the declaration of conformity and technical documentation are in place and to handle a range of other tasks, many of which relate to the provision of information and interfacing between the manufacturer and regulator. 

Those responsibilities could lead to a UK Responsible Person being the subject of a liability lawsuit. The manufacturer’s insurance may cover the UK Responsible Person in the event of a legal case.

The near-term need for companies to establish a UK Responsible Person could be eliminated by the passage of an exit deal between the U.K. and EU. However, there a major doubts about whether a deal will happen. In recent days, senior figures within the EU and its member states have said “the risk of a no-deal is palpable” and describing that outcome as “quite likely," as reported by Politico and Reuters.