Health Bill Amendment Signals a Potentially Major Shift in UK HealthTech Regulation
Amendments to the Health Bill have been tabled that could change the way medical devices are regulated in Great Britain. Of particular interest to HealthTech companies is Government New Clause 94, which would create a legal basis for a future licensing framework for medical devices.
This is an enabling power, not a finished operating model. Even if passed, it would not mean an immediate move to a new licensing system for devices. The practical impact for medical device and IVD companies, software developers, importers and distributors would depend on later policy development and secondary legislation.
Implementation will therefore matter as much as the power itself. One early question is whether a licensing model would support MHRA's direction of travel on international recognition and reliance, or create a more distinct UK-specific assessment route. This matters not only for access to the UK market, but also for members seeking to use UK regulation as part of their international growth plans.
The amendment could allow future regulations to require product licences for the supply and advertising of devices, and personal licences for activities such as manufacturing, importing, wholesale supply and clinical investigations.
The amendment is high level and does not distinguish between general medical devices, IVDs and software. IVDs are undergoing significant regulatory change internationally, while software and AI-enabled technologies often change continuously after being placed on the market. A future licensing framework could either make it easier to manage these product types through proportionate lifecycle controls, or add unnecessary complexity if implementation is not carefully designed.
Recognition and reliance will be central to this discussion. A future MHRA licence could potentially be granted on the basis of trusted approvals and assessments from other jurisdictions. It could also help UK regulatory decisions carry greater practical value overseas, if the framework is designed in a way that other regulators can understand and use. Equally, licensing could develop into a more separate GB route. The amendment itself does not answer that question.
The wider package of amendments is also relevant. Alongside the licensing power, Government has proposed expanded powers for sharing information about devices, powers to amend the meaning of "medical device" and powers to restate device law in Northern Ireland. Government has also proposed separate provisions on guidance for the governance, monitoring and audit of AI systems used in health and care settings. Taken together, the amendments suggest a broader attempt to create more flexible legal tools for future regulation.
For now, members should be cautious about drawing firm conclusions. The amendment is an important signal, but the real test will be how any future regime is designed, consulted on, resourced and implemented.
ABHI will be watching several issues closely:
- How the system will be resourced.
- Whether recognition and reliance remain central to the future regime.
- How IVDs, software and AI-enabled technologies are treated.
- Whether UK approvals can support international acceptance as well as domestic supply;
- What role UK Approved Bodies play.
- How overseas approvals are recognised.
- How fees and transition arrangements are handled.
- Whether the final model supports patient access, supply continuity and international growth for UK HealthTech.
ABHI will continue to engage with Government and MHRA as the Bill progresses. Our focus will be on ensuring that any future framework is proportionate, practical and aligned with international approaches, so that regulation supports timely patient access in the UK while strengthening the value of UK regulatory decisions for members operating globally.
