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Brexit, what will it mean for the medical medical device approval process?

How will Brexit affect the regulation of medical devices?

In the short term, before the UK government triggers article 50 of the Treaty on European Union (which starts the formal process of the UK leaving the EU) there will of course be no change.

After article 50 is invoked, there will be negotiations around the terms of relationship between the EU and the UK once the UK leaves the EU, during this period (which could take up to two years) there will equally be no change to the current arrangement.

What about afterwards?

The UK is a full voting member of the European Committee for Standardisation (CEN), which is unlikely to change, no matter what the UK’s new relationship with the EU looks like. So it is likely that CEN standards will continue to be applicable to UK developers and manufacturers, unless the UK were also to renegotiate its relationship with CEN.

If the UK follows Norway’s footsteps and signs the European Economic Area (EEA) agreement, or opts for the European Free Trade Association (EFTA) agreement like Switzerland, there would be little or no impact on UK’s regulatory approval of medical devices. Even if the UK completely disassociates with the EU and decides to leave the CEN, it could build a relationship with Europe through the World Trade Organization’s (WTO) established trade rules, and it still could establish a UK-based regulatory system that unilaterally recognizes CE Mark certification as evidence on which to grant approval.

Australia recently adopted such a system for all but the highest-risk devices in an effort to streamline the approval process by reducing both time and cost necessary for medical device approval.

Also, it seems probable that EU manufacturers aiming to sell into a UK market would seek to utilise the standards applicable to the much larger EU market. In any case, on a global scale regulations are tending to converge. The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization. It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.

So the best guess is that the regulatory approval process for medical devices is unlikely to change significantly in the UK, medium term either.

But also, it is very difficult to make predictions, especially about the future, so we can’t assume it will be like deja vue all over again. (Acknowledgements to Yogi Berra).

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