The UK Government tabled three amendments to the Health Bill aimed at modernising the legislative framework for regulating medicines and medical devices, the Medicines and Healthcare products Regulatory Agency said in a report published on 1 September 2026. The measures, which now face parliamentary scrutiny, do not introduce immediate changes to regulation, and any agreed measures would need further development and consultation before implementation.
The first amendment would give the MHRA clearer legal powers to share specific information on medicines and medical devices with trusted UK government organisations and global regulatory partners where this supports public health, patient safety, access to innovation and effective regulation. Existing safeguards, statutory criteria and proportionality requirements would remain, and commercially sensitive and patient information would stay protected under data protection legislation and patient consent.
The second amendment is intended to make regulation more responsive to science and technology, allowing legislation to reflect future updates to technical standards and international guidelines, and supporting targeted engagement for minor changes while keeping full public consultation for significant reforms. The third would provide enabling powers, by amending the Medicines and Medical Devices Act 2021, for a future licensing regime under which devices placed on the Great Britain market through a domestic route could require an MHRA licence rather than third-party conformity assessments. Detailed design would follow further policy work, consultation, impact assessment and scrutiny. The UKCA regime would remain in place while any model is developed, and Northern Ireland continues to apply EU rules under the Windsor Framework.


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