MHRA regulatory reform amendments tabled in UK Government’s Health Bill

The UK Government has tabled three amendments to the Health Bill that could help shape the future regulation of medicines and medical devices in the UK.

The Medicines and Healthcare products Regulatory Agency (MHRA) has recently announced the proposals, which cover amended information-sharing powers, measures to make medicines and medical devices legislation easier to update, and enabling powers to support a future medical device licensing regime.

There are no immediate changes to medical device regulatory requirements as a result of the proposals.

What is the MHRA proposing?

Clearer information-sharing powers

The first amendment would give the MHRA clearer legal powers to share specific information about medicines and medical devices with trusted UK government organisations and global regulatory partners.

The MHRA says the changes would support public health, patient safety, access to innovation, and effective regulation.

Safeguards would remain in place, including statutory criteria governing when information can be shared and requirements to ensure that sharing is necessary and proportionate. Commercially sensitive information and patient data would continue to be protected.

Making regulation easier to update

The second amendment is intended to make medicines and medical devices legislation easier to update as science and technology develop.

It would allow legislation to automatically reflect future updates to certain documents, including technical standards and international guidelines. The intention is to help the regulatory framework keep pace with scientific and technological developments without requiring legislation to be amended each time relevant documents are updated.

The proposals would also enable a more proportionate approach to consultation. Technical, administrative, or minor regulatory changes could be subject to more targeted consultation, while significant policy changes would continue to involve full public consultation.

The government is also proposing changes to how some regulatory updates are handled by Parliament. Technical, administrative, or minor regulatory changes could become law unless Parliament objects.

Supporting a future medical device licensing regime

Potentially the most significant proposal for medical device businesses is the creation of enabling powers to support a future medical device licensing regime.

The amendment would make changes to the Medicines and Medical Devices Act 2021, providing the legal foundation for a future framework.

Under the approach being explored, medical devices placed on the Great Britain market through a domestic route could in future require a licence issued by the MHRA, rather than relying on third-party conformity assessments.

The enabling powers would not themselves introduce a medical device licensing regime. The detailed design of any future framework, and how it would interact with the existing regulatory system, would be developed with stakeholders.

The MHRA says any future system would take a risk-proportionate approach, and would be subject to further policy development, public consultation, impact assessment, and parliamentary scrutiny. The aim is to support a modern and adaptable framework capable of responding to emerging technologies, including software and AI-enabled medical devices.

The UKCA regime will remain in place in Great Britain while any future model is developed, and the MHRA says its intentions concerning international reliance and recognition remain unchanged.

Northern Ireland will continue to apply the EU Medical Device and In Vitro Diagnostic Regulations under the Windsor Framework.

Health Bill context and next steps

The MHRA’s proposals have been tabled as amendments to the Health Bill, which already contains measures relating to medicines and medical device regulation.

The current version of the Bill includes provisions concerning technical standards, international regulatory requirements, consultation, and parliamentary procedure. The three newly tabled amendments would add to and develop these existing regulatory reforms and are not reflected in the current published version of the Bill.

The amendments will now be considered as the Health Bill continues its passage through Parliament. Where further measures are required, these would be subject to additional development and consultation before being implemented.

The BHTA will continue to monitor developments and keep members informed as further details emerge.