The Government has tabled amendments to the Health Bill that would modernise how the MHRA regulates medical devices, including enabling powers to build a future domestic device licensing regime by amending the Medicines and Medical Devices Act 2021. These are enabling powers only: nothing changes immediately, UKCA marking stays in place, and each measure needs further consultation before it could take effect.
TL;DR · LAST REVIEWED 1 SEPTEMBER 2026
- The Government tabled three amendments to the Health Bill on 1 September 2026 to modernise MHRA device regulation.
- They cover information sharing, faster regulatory updates, and powers for a future domestic device licensing regime.
- These are enabling powers only; nothing changes immediately and UKCA marking stays in place.
The three MHRA amendments to the Health Bill
| Amendment | What it would do |
| Information sharing | Clearer MHRA powers to share device data with UK and global regulators, with existing safeguards |
| Regulatory reform | Lets legislation auto reflect updated technical standards; proportionate consultation for minor changes |
| Device licensing powers | Enabling powers for a future domestic MHRA device licence, amending the 2021 Act |
Source: MHRA and GOV.UK, 1 September 2026
KEY FACTS
- The Government tabled three amendments to the Health Bill on 1 September 2026 (MHRA).
- One would give the MHRA clearer powers to share device information with UK and global regulators.
- One would let device legislation automatically reflect updated technical standards, with proportionate consultation.
- One would create enabling powers for a future domestic device licensing regime, amending the Medicines and Medical Devices Act 2021.
- The amendments make no immediate changes; UKCA marking remains in place while any future model is developed.
What has been tabled
The Medicines and Healthcare products Regulatory Agency, the MHRA, has had three amendments tabled to the Government's Health Bill, forming part of a wider programme of regulatory reform. The three areas are amended information sharing powers, measures to make medicines and medical device legislation easier to update, and powers to support the future development of a medical device licensing regime. The proposals introduce no immediate changes and will now be subject to parliamentary scrutiny as the Bill moves through its remaining stages.
Why the reform, and why now
Since leaving the EU, Great Britain has regulated medical devices largely through UKCA marking assessed by a small number of third party approved bodies, which creates capacity and resilience pressures. At the same time, the pace of change in software and AI enabled medical devices has outrun a framework that cannot easily track evolving technical standards. The reforms aim to let the rules update in step with science, share safety data more effectively with global regulators, and lay the legal foundation for a domestic licensing route, reducing sole reliance on third party conformity assessment.
What it could mean for device makers
The most significant proposal is the enabling power for a future domestic 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 a third party conformity assessment. Any such system would be proportionate to risk, with different levels of scrutiny by product type, and is expected to accommodate software and AI medical devices. The detail would be designed with stakeholders through further policy work and consultation.
What is not changing yet
It is important for manufacturers to note what these amendments do not do. They make no immediate change to how medicines or medical devices are regulated. Any measures agreed would require further development, impact assessment, public consultation and parliamentary scrutiny before implementation. UKCA marking remains in place in Great Britain while any future model is developed, and stated policy on international reliance and recognition is unchanged. Northern Ireland continues to apply the EU device rules under the Windsor Framework.
DISCLAIMER
This article is editorial information, not financial advice. Kael Tripton Ltd is not authorised or regulated by the Financial Conduct Authority. Figures were correct at the last review date shown above; verify current rates and rules with the primary sources listed below before acting.
Frequently asked questions
What has the MHRA proposed
The Government has tabled three amendments to the Health Bill covering information sharing about devices, easier updating of device legislation, and enabling powers for a future domestic medical device licensing regime.
Does anything change now
No. The amendments are enabling powers and make no immediate change. Any measures agreed would need further development, consultation, impact assessment and parliamentary scrutiny before taking effect.
What is the future device licensing regime
A proposed domestic route under which medical devices on the Great Britain market could in future require a licence issued by the MHRA, rather than relying on a third party conformity assessment, proportionate to the risk of the product.
Does this affect UKCA marking
Not yet. UKCA marking remains in place in Great Britain while any future licensing model is developed, and policy on international reliance and recognition is unchanged.
What about Northern Ireland
Northern Ireland continues to apply the EU Medical Device and In Vitro Diagnostic Regulations under the Windsor Framework, maintaining dual market access to the EU and the rest of the UK.
SOURCES
- GOV.UK: MHRA regulatory reform amendments tabled – accessed 1 September 2026
- GOV.UK: MHRA – accessed 1 September 2026
