HDA UK Media and Political Bulletin – 19 July 2021

Media Summary

Medical devices industry tests UK plans for post-Brexit divergence
Financial Times, Peter Foster, 18 July 2021

The Financial Times reports that industry experts have suggested that if the UK diverges from EU standards it will have less chance of becoming a global innovation hub for new medical devices post-Brexit.

Following Brexit, the UK chose not to implement the EU’s new Medical Device Regulation (MDR), which places responsibility on companies to prove devices are both safe and beneficial for patients.

The UK is looking to implement a bespoke regulatory system. Minister for Innovation, Lord Bethell, said this month is intended to “grasp the opportunity of innovation now we have left the EU”.

However, academics and leaders from the sector have warned that the UK must mirror the EU system because British companies sell their products in Europe, therefore companies have to comply with MDR regardless of the UK regulation.

Additionally, James Moore, Professor of medical device design at Imperial College London, said a divergent UK regulatory system could limit investment. Others argue that a unique UK system could put further burdens on companies.

The MHRA said that it was aiming to develop a “best-in-class” regulatory environment that would build on international best practice. The article highlights that the UK could become less bureaucratic through better regulation of software in medical devices, including a lighter touch regime for low-risk items and faster interactions with early-stage companies.

The UK Government has agreed to continue recognising the EU’s standard “CE” mark until July 2023, while it develops a new regulatory system.

A consultation will start this summer with secondary legislation clarifying new rules expected in the spring of 2022.


 Parliamentary Coverage

 There was no parliamentary coverage today. 


Full Coverage

Medical devices industry tests UK plans for post-Brexit divergence
Financial Times, Peter Foster, 18 July 2021

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HDA UK Media and Political Bulletin –  19 July 2021

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