Since Brexit, the MHRA’s regulatory framework for medical devices hasn’t changed much. Will the Government’s acceptance of all 44 of the National AI Commission’s recommendations bring about some much-needed reform?
Last month, the National Commission on the Regulation of AI in Healthcare published 44 recommendations on how the current regulatory frameworks in the UK must adequately adapt to oversee AI medical devices. This month, the UK Government accepted all of them. Many experts have already commented on the individual recommendations. In this piece, we step back to look at the bigger picture. What are the potential implications of the UK Government’s response? 4 themes emerge:
A shift towards FDA alignment over EU alignment
The need to resolve inconsistencies in the MHRA’s current regulatory oversight
Novel elements introduced by the proposed reforms
Alignment with the MHRA’s 2030 Strategy
1: Favouring FDA alignment over EU alignment
For over a year, the MHRA has been working to open international reliance routes, particularly with FDA 510(k) cleared products. Taken together, these point to a broader shift in policy direction towards FDA-style approaches over the EU’s, at least in language. This should be read alongside the MHRA’s recent announcement that it intends to accept CE-marked medical devices and IVDs on the GB market indefinitely.
In practice, UK regulation is therefore likely to become a hybrid. It would build on the existing UK MDR and incorporate new concepts from the FDA, while continuing to accept CE-marked devices.
It remains to be seen whether this approach will make UKCA marking attractive to manufacturers at all. Recognition of FDA and EU approvals may instead draw them away from pursuing a UKCA mark directly. In our experience, EU MDR requirements can be cumbersome and convoluted for the newest AI devices, so new UK regulations may offer a more efficient route to market. However, the European Commission is also working on a more streamlined “MDR 2.0”, which may once again reduce the appeal of conforming directly with any new UK regulations.
2: Addressing inconsistencies in regulatory enforcement
The MHRA’s current positions show a general inconsistency in how strictly UK regulations are interpreted.
On one hand, the MHRA recently published guidance that effectively deregulated ambient voice technologies by classing them as administrative tools. This brings the UK in line with the US, and partly with Australia.
On the other hand, last year’s Digital Mental Health Technology guidance took a much stricter view of what counts as a medical purpose in mental health technologies. This contrasts with the FDA and TGA, where many such devices would fall into the largely unregulated categories of general wellness or mobile medical applications under enforcement discretion.
The Government’s response refers repeatedly to lowering the regulatory burden for low-risk tools, with “carve-outs for certain software and AI-enabled products that would not be regulated as medical devices”. These include certain clinical decision support and general wellbeing functions. We hope the incoming regulations and guidance will take a more consistent approach to device qualification. Whether that approach ends up more or less stringent is almost secondary. What matters most now is giving manufacturers clarity on their regulatory obligations.
3: Novel elements
Alongside ongoing policy discussions on international recognition of CE-marked and FDA-cleared devices, the Government’s response points to several novel elements being considered for the new framework:
A broader approach to PCCPs than the FDA’s. This could be a net positive compared with the FDA’s restrictive and overly prescriptive approach.
Provision for general-purpose products. Neither the FDA nor the EU accommodates these particularly well.
Staged authorisation of novel products. This would allow risk-proportionate entry into the market.
These elements are a double-edged sword. On one hand, they are sensible and reflect how quickly AI and software devices are evolving. They would allow more efficient market access for innovative technologies, with mechanisms for continuous improvement.
On the other hand, taken too far, they risk turning the UK into a “pilot ground”. Manufacturers could reach the market faster here while gathering the more robust data EU and FDA clearances require, since those regulators offer no equivalent accommodations. If the balance is not struck carefully, this could put patients at risk.
Manufacturers will also need to consider whether evaluation data collected in the UK market and healthcare system would even apply to the EU or the US.
4: Lining up with the 2030 plan
This month, the MHRA also published its 2030 Strategy, a five-year plan to modernise and reform its processes across the board. For MedTech and AI in particular, the strategy aligns well with the Government’s response to the Commission’s recommendations, though it remains very high-level. The overall direction is nonetheless promising.
Closing thoughts
This is both an exciting and a destabilising time for the UK as the MHRA works to reform its regulatory framework. On the ground, we see many manufacturers treating this uncertainty as a reason to seek FDA or EU approval first. That route is a safer way to reach more markets without giving up the UK.
Taking a more optimistic view, other jurisdictions may begin to align more closely with the MHRA’s approach in the coming years if the reforms succeed. That would re-establish the UK as a leader in enabling safe and effective access to novel medical technologies.
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