Introduced in the government’s Health Bill, they aim to support information sharing, regulatory reform and the future development of a medical device licensing regime.

The government has tabled three amendments to the Health Bill aimed at modernising the legislative framework for the regulation of medicines and medical devices in the UK. The measures form part of a wider package of reforms that impact the Medicines and Healthcare products Regulatory Agency (MHRA) and will now be subject to parliamentary scrutiny.

The first amendment aims to give the MHRA clearer legal powers to share specific information about medicines and medical devices with relevant trusted UK government organisations and global regulatory partners, where this supports public health, patient safety, access to innovation and effective regulation.

The second amendment intends to make medicines and medical device regulation more responsive to developments in science and technology. Proposals would allow for legislation to reflect future updates to documents including technical standards and international guidelines, enabling live changes and supporting smarter and faster regulation. In addition, the proposals aim to support a more proportionate approach to consultation, which would enable targeted engagement for minor changes, while maintaining full public consultation requirements for significant policy reforms.

The third amendment would provide the MHRA with enabling powers for the development of a future medical device licensing regime. 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.

In a statement, the government said: “These three amendments will form part of a broader programme of regulatory reform to ensure the MHRA remains flexible, balanced and capable of responding to scientific and technological change.”

The amendments will be considered as part of the Bill’s remaining stages through Parliament.