The Government has tabled three amendments to the Health Bill, which are intended to modernise the legislative framework for regulating medicines and medical devices in the UK. These proposals are part of wider reforms impacting the Medicines and Healthcare products Regulatory Agency (MHRA) and will now undergo parliamentary scrutiny.
The amendments focus on three areas: updated information sharing powers for medicines and medical devices, measures to simplify updates to legislation, and powers to support the future development of a medical device licensing regime. These proposals do not introduce immediate changes, and any agreed measures would require further development and consultation before implementation.
One amendment aims to grant the MHRA clearer legal powers to share specific information about medicines and medical devices with relevant UK government organisations and global regulatory partners. This is intended to support public health, patient safety, access to innovation, and effective regulation, while existing safeguards for sensitive information would remain.
Another amendment seeks to make regulation more responsive to scientific and technological advancements by allowing legislation to automatically reflect future updates to technical standards and international guidelines. This would also enable a more proportionate approach to consultation for minor changes.
The third amendment would provide the MHRA with enabling powers to develop a future medical device licensing regime. This would amend the Medicines and Medical Devices Act 2021, creating a legal foundation for a framework where medical devices on the Great Britain market might require an MHRA licence instead of third-party conformity assessments.