Sadik Al-Hassan MP: ‘Why the upcoming Health Bill must close the regulatory gap’

A decade after the Brexit vote, new arrangements for the regulation of medical devices are finally taking shape. Medical devices, including diagnostic and digital health technologies, are essential to the delivery of modern healthcare, and are relied upon by millions of people across the UK every day.

Products are, necessarily, highly regulated and undergo close scrutiny once in use. The future regime will offer a blended approach, maintaining CE recognition alongside the consideration of approvals from other, trusted jurisdictions such as the US, Canada, and Australia.

A key component will also be a bespoke route to the UK market, and one which could help make our country an attractive destination for innovative technologies, such as those currently being considered by the National Commission into the regulation of AI in healthcare. Yet, for any of these pathways to function effectively, we must address the fundamental legal omission at the heart of our domestic regulator.

To make this new era successful, protect the supply of life-saving and life-enhancing technologies to NHS patients, and offer global manufacturers long-term confidence in the UK, it is important that the MHRA now has the necessary powers to approve products in its own name. We cannot rely on a patchwork of international workarounds without giving our sovereign regulator the baseline legal authority to make independent product determinations.

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The upcoming Health Bill, announced in the king’s speech, provides the perfect legislative vehicle to fix this problem. The bill will be slim, and the government will be anxious that it passes quickly, such that the abolition of NHS England can be completed by next April. However, the government has not steered away from addressing tricky issues in this legislation, such as those around data sharing to create a unified single patient record.

Whilst those data-sharing clauses may prove contentious during parliamentary scrutiny, using the legislation to give our regulator the powers most people believe it already has, would not. The bill presents an immediate opportunity to secure supply continuity, elevate patient safety, and restore global industry confidence in the UK.

This vital correction could be achieved smoothly through a short, completely uncontroversial amendment. We must seize this moment to build a resilient, modern regulatory framework that protects British patients and accelerates NHS innovation.