Broad changes to MHRA proposed under UK Health Bill

The Government has proposed a series of reforms to the UK’s regulatory framework for medicines and medical devices, designed to modernise the MHRA and speed up how quickly the law can respond to future developments in science and technology. The amendments to the Health Bill, which is currently going through Parliament, would facilitate future regulatory reform by introducing a licensing regime and new powers to update regulation. 

These amendments are in addition to those currently provided for in the Health Bill which include amending the duty to consult on regulations relating to medicines and medical devices as well as changing the legislative procedure for certain regulations from the affirmative procedure (e.g. which requires Government approval) to the negative procedure (e.g. which requires Ministerial approval only).

The proposed amendments do not require manufacturers and businesses to take immediate action nor do they change the existing legislative framework. Rather, the proposed amendments will pave the way for the development of future legislation and policy, which will likely be subject to further consultation. 

What are the proposed amendments?

The proposed amendments concern three key areas of change:

1. Future medical device licensing regime: this proposal would amend the Medicines and Medical Devices Act 2021 (the “Act”) to include a new power for the Secretary of State (the “SoS”) to create future regulations for the licensing of medical devices in the UK. This could see MHRA granting licenses for medical devices under a new regulatory regime, rather than using third-party Approved Bodies. 
2. Regulatory reform measures: as well as the power for the SoS to introduce new medical devices regulations, it is proposed that the Act is amended to enable the SoS to make consequential amendments to regulations. This would enable the SoS to update regulations to respond to changes in, for example, international guidelines or technical standards, more quickly.
3. Information sharing: the proposed amends seek to give clearer powers to MHRA to share information about medicines and medical devices with UK government and international regulatory partners where this supports public health, patient safety and effective regulation. The disclosure of such information will remain subject to existing safeguards.

The Health Bill, introduced in the House of Commons in May 2026, is progressing through the Report Stage. During the Report Stage, Parliament will consider new amendments to the bill which could form the basis of future regulatory requirements for medical devices and medicines in the UK.

We will be tracking how these proposals develop. If they become law, next steps will be to review any secondary legislation which may be introduced and respond to public consultation.

If you would like to discuss further, please contact a member of our Health, Care and Life Sciences Team.

This article was written by Lisa Mulholland and Rory Trust.