UK Medical Device Industry Has Concerns Over Divergence From EU Standards

Leaders from the UK’s medical device sector have expressed concerns that the UK will run into damaging problems if it continues with plans to diverge from EU standards post-Brexit. It is feared that any ambitions for the UK to become a global innovation hub for new medical devices will be thwarted.

The Financial Times reports that Kevin Kiely, the chief executive of Medilink UK, a professional association that represents more than 1,300 small businesses making medical devices, said the UK system “absolutely” needed to mirror the EU system because that is where British companies sold their products.

Kiely commented: “The early drafts have not been encouraging. 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.”

A formal government consultation process is due later this summer, amid growing concerns from both industry and academia that the UK was set to take the wrong course of action with regard to future regulation.

The EU’s new Medical Device Regulation (MDR) places more burden on companies to prove the safety and efficacy of their devices, following a number of safety scandals. The UK has decided to create a bespoke regulatory system post-Brexit, with the aim of creating a more agile and innovative industry.

However, the UK medical device industry is heavily reliant on exports to EU markets, according to The Financial Times. It is feared that as well as damaging exports, British innovation will be wasted because investors would prefer to register devices in the EU or the US, which make up 43 per cent of global healthcare spending.

As it stands, the UK government has agreed to continue recognising the EU’s standard “CE” mark until July 2023.

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