Taking over from Dame June Raine as the Medicines and Healthcare products Regulatory Agency’s (MHRA) CEO in April 2025, Lawrence Tallon has big plans for the agency’s approach to the regulation of medical devices under his leadership.
Significant overhauls to the MHRA’s approach to medical device regulation include the agency’s work on developing the Early Access and Innovation Programme (EAIP), a regulatory pathway mooted to get innovative medical devices to patients sooner, ahead of full regulatory approval, albeit in a controlled and evidence‑generating manner.
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With the rise of medical devices that feature an artificial intelligence (AI) component or are characterised under the designation of AI/software as a medical device (SAMD), the MHRA is preparing for a broader shake-up to its regulatory approach.
Set to be informed by the National Commission into the Regulation of AI in Healthcare, which is due for publication later this year, a step-change to adapt regulatory protocols in line with the uptick of AI and related technologies’ interplay with medical devices is imminent.
A significant shift that aims to further modernise the MHRA’s regulatory approach to medical devices lies in the adoption of more stringent post-market surveillance protocols. This initiative builds on the agency’s Post-market surveillance (PMS) regulation, which came into force in June 2025.
Medical Device Network spoke with Tallon during the Medtech Forum, which took place in Stockholm, Sweden, between 11 and 13 May, to learn more about his aims for the agency and how its evolving approach to medical device regulation aims to advance the regulator’s leadership on the global stage.
This interview has been edited for length and clarity.
Ross Law (RL): As MHRA CEO, what are your top priorities in the coming years?
Lawrence Tallon (LT): Since assuming the role of CEO, my key priorities have been to get on top of the core performance of our regulatory services, making sure that we’re delivering timely, predictable services to our customers so they can quickly get their products to market.
Putting patients first has long been the motto of the MHRA, and one of the crucial elements towards this aim is ensuring we have the right and rigorous standards of safety, both pre- and post-market.
Having got on top of our performance now and becoming faster and more predictable in our services, I want to look ahead to the future of regulatory sciences. As an example regarding medical devices, this may be leading the thinking globally on topics such as AI as a medical device.
RL: What culture are you aiming to build at the MHRA?
LT: I believe in a culture of trust, openness, and empowerment. Post-Brexit, we’ve grown substantially as an organisation, and have the number of staff back that we need. We’ve also got the expertise available to us. One of the things we’re lucky about in the UK is the strength of our academic and industry sectors, meaning we can staff the organisation with some of the best experts in their field. I want those people to be able to operate in a culture of trust, openness, and empowerment, where they can take appropriate, risk-calibrated decisions in the best interests of patients.
RL: Discuss the MHRA’s early access and innovation programme (EAIP). What impact do you expect it to have on patients and industry?
LT: I think there’s a huge opportunity here, partly because, as a country, we are increasingly coming under the UK government’s 10-year plan for the health service and its long-term plan for the life sciences sector. We’re becoming an increasingly attractive place to develop, launch, and grow innovative products and devices. However, we’ve got to continue to make sure that we get the pull-through, all the way from invention to scale in the UK. This end-to-end piece is the challenge, which we are increasingly addressing, but there’s still more work to do.
Our thinking around early access to devices is to do that pull-through, where you get the regulation, business, and reimbursement environment right, and you get the uptake and adoption within the UK National Health Service (NHS). We know that the system has currently been a bit too fragmented, and so our thinking around early access to innovative devices is to do a concierge pull-through, so that innovative products that meet an unmet need can get to market more quickly.
RL: More generally, how is the UK medical device regulatory framework evolving?
LT: We are in the middle of a radical reform programme on the way we do medical technology regulation. The way that a lot of regulation has been set up has been around biopharmaceuticals and small-molecule medicines that have very long lead in times and high barriers to entry, given the high expense of developing medicines.
But we’re now in an era where we also need to be thinking about new categories of products, such as AI-enabled medical devices. And, particularly around SAMD, none of the tenets I’ve just described is necessarily true.
The barrier to entry may be much lower for market participants, because an app can be developed with far quicker lead times, and you don’t need the same deep pockets as big pharma. We need to adapt the regulatory paradigm to do the things we used to do traditionally around big pharma, but also to adapt to these new models. Crucially, we need to do that in a way where we bring international harmonisation recognition with us. We could design a brilliant new regulatory framework for those adaptive products in the UK, but if that’s not recognised in other jurisdictions, developers are still going to have the problem that they’re going to have to go through multiple international jurisdictions.
RL: How is the MHRA’s regulatory approach around AI-based medical devices advancing?
LT: We’re coming towards the later stages of a major exercise in the UK called the National Commission on the Regulation of AI in Healthcare. The final report from this initiative will be published in September, and there are three key themes I expect to see come out of it.
The first is the risk of inaction as a regulator, as well as the risk of action. So, clearly, if we license a product, we need to think about what might happen with that product. What are the risks, and how do we control for those risks? We also need to be thinking about the risks if we don’t bring innovative products to market.
The second big message is a shift towards post-market surveillance. Of course, we need to have an appropriate barrier to market entry, but as well as that pre-market hurdle, we’ll then have more adaptive post-market surveillance on real-world data, which we have not traditionally relied on as much as we will. I think this is going to be crucial to the paradigm of regulation for AI.
The third big shift relates to context-specific regulation, so not only looking at the device but also looking at the professionals and healthcare institutions using that device, and whether they have the right systems of clinical governance to understand where errors might occur. Context-specific regulation also relates to the provider of that product, and whether they’re reporting transparently and openly their safety signals in real-world data, and whether they’re maintaining their model post- market, and then, of course, whether the product itself is appropriately safe.
In terms of post-market surveillance, we’ll have far greater use of predetermined change control plans, meaning that a product developer can agree up front on how much change is acceptable post-market before they have to come back for regulatory approval. That’s something the US Food and Drug Administration (FDA) has championed, and we intend to do a lot more of that ourselves as well.
RL: From a high level, what is the MHRA’s approach to balancing safety and innovation?
LT: The way I think about this is driven by the MHRA’s guiding philosophy of putting patients first. Patients want to be sure that any time they’re accessing a product on the UK market, it meets appropriate standards of safety, and that we would not allow products either to be initially licensed or to continue in market if they didn’t meet those appropriate standards of safety.
We also need to think about access to innovative products, and it’s not actually helping patients if we don’t find ways to appropriately facilitate access to the latest health technologies that might give them better diagnosis, treatment, and outcomes.
RL: Looking 10 years into the future, what would your expectation for the MHRA be?
LT: Already now, but more so over time, we want to be seen as an agile, pragmatic, and trusted regulator. By fast, if you look at our approval times now, they’ve come down radically in recent years, but we think we can go further to become one of the quickest, but still rigorous and safest, regulators in the international environment.
The second area is in becoming an expert in areas of regulatory or technological science, where we can be differentiated as a country. Whether it’s in areas such as AI as a medical device or rare disease therapeutics, our aim is to be a thought leader for the international community.
The third is open. We’re, of course, a sovereign regulator that looks after the UK, but we exist within an international ecosystem where we are increasingly comfortable with international reliance and recognition. In some areas, we will be the thought leader where we set standards that others will follow, and in other areas, we will recognise the standards of others. So, fast, expert, open. I think we are now, but I think we can be even more so 10 years out into the future.
This interview is an abridged version of a conversation Medical Device Network conducted with Tallon at the Medtech Forum. You can listen to the full conversation here.
