Letter: Health tech industry wants action on post-Brexit regulations


Peter Foster (British after Brexit Newsletter, FT.comOctober 6) detailed the boardroom headaches resulting from the current inertia and uncertainty surrounding the development of new regulations that the UK will need to introduce post-Brexit.

This is something well recognized by the health technology industry, an employer of 138,000 people in the UK, with these issues likely to create additional challenges for a sector identified in the government’s paper on ” vision of life sciences” as an engine to drive future health and wealth. of our country. We agree that urgent action is needed to complete the necessary legislative processes. The current dual regulatory regime recognizing both EU and UK certificates is helpful and our members wonder why this is not an arrangement that could be made more permanent.

Regulation exists to protect consumers and, in our industry at least, the content is 80% the same across the world. It would then make sense to consider extending unilateral recognition to other trusted jurisdictions such as the United States and others that are part of existing internal collaborations.

There are around 600,000 registered medical devices in Europe and they are all available to the NHS. We must consider the potential impact on the supply of life-saving and improving technologies if we create additional and costly bureaucratic hurdles for what is a relatively small market. The current deadline of June 2023 for the introduction of a fully operational UK ‘Conformity Assessed’ marking – which after Brexit replaces the old CE marking used across the EU – remains in the legislation, but the date is increasingly unrealistic.

Brexit gives us certain regulatory freedoms and it is possible to use them to our advantage, but to protect our NHS and the patients we serve, and to grow this key sector, action must be decisive and swift.

Peter Ellingworth
Managing Director, Association of British HealthTech Industries, London W1, UK


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