Post Brexit, the UK has decided against implementing the EU’s new Medical Device Regulation, which places more responsibility on companies to prove devices are safe and deliver patient benefits.

The UK aims to “grasp the opportunity of innovation now we have left the EU”, according to the health department’s innovation minister. But there is a significant dependence on exports to EU markets, which constitute over 20% of global healthcare spending according to Imperial College, London, unlike a mere 3 per cent in the UK.

“The UK absolutely has to reflect EU regulation “

The chief executive of Medilink UK (which represents over 1,300 small businesses making medical devices) claims the UK “absolutely” has to reflect EU regulation because “the reality is that we’ve got to sell into Europe, so all companies have to comply with MDR anyway. The last thing they need is yet another audit trail that duplicates what they already have to do in Europe.” Investors would need to devote time and finance to register medical devices in the US or EU (responsible for 43% of international health spending); therefore, senior academics believe there is a real risk of losing the benefits of British innovation. Professor of medical device design at Imperial College, James Moore, claimed that the new legislation might discourage investment and cause the UK to hold fewer successful medical device products.

Forte Medical UK’s chief executive pointed out that market innovators are not doing well currently due to multiple dominant firms exiting the market, with just three approved bodies remaining for UK medical devices. The UK’s most prominent medical technology industry body, the ABHI, worked alongside the UK regulator (the Medicines and Healthcare products Regulatory Agency) to incentivise investors and businesses to introduce products in the UK through government regulation.

The UK aims to move away from the structured approach of the EU system to achieve improved regulation of medical device software, a specific set of rules for low-risk items, and quicker communications with businesses in the start-up phase. Neelam Patel, the chief executive of MedCity, said: “The MHRA has a good opportunity to use what is current and evolve it to long term needs, not only for patients but also companies and markets as a whole.” The UK parliament will continue to identify with the EU standard until the UK system begins in July 2023.