Medical device regulation is a notoriously complex beast, particularly when it comes to emerging technologies. On one hand, any regulatory framework needs to promote innovation. It should create a smooth, streamlined pathway from manufacturer to patient, without putting up unnecessary roadblocks along the way.
On the other hand, safety is paramount, especially given that patients’ lives may be at stake. This is a delicate balancing act, which needs to evolve in tandem with medtech itself. As entirely new categories of device reach the market, including those based on machine learning and artificial intelligence (AI), it’s imperative that they’re regulated in a proportionate and patientcentred way.
“Having regulations keep pace with the speed of development is a trend we’re witnessing across geographies,” says April Chan-Tsui, director of product operations and medtech insights at Clarivate. “This has led to the successful approval and launch of major, impactful life-saving technologies much faster than was the case in the past.”
She cites the breakthrough devices designation in the US, and the Green Pathway in China, as two programmes that aim to do just that. They seek to bring cutting-edge technologies to market on a much-compressed timeline, benefitting the industry and patients alike.
Regulatory reform
Much like its international counterparts, the UK is keen to position itself as a hub of medtech innovation. In January 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published its latest roadmap, which sets out a comprehensive plan for medical device regulatory reform.
“The new framework will strengthen the MHRA’s ability to keep patients safe, while at the same time contributing to an environment which encourages the launch of the most innovative healthcare products that make a real difference to the public’s health,” said Dr Laura Squire, the MHRA’s medtech regulatory reform lead. “The roadmap sets out how we will work with stakeholders including patients as the process moves forward, giving early sight of what is to come and giving us feedback about the guidance they will need, to ensure the successful implementation of these wide-ranging UK reforms.”
The roadmap starts with a timeline showing what was achieved in 2021–23, before moving onto the MHRA’s plans for 2024–25. The immediate goal, says the agency, is to implement priority measures protecting patient safety. It will then address core aspects of the new regulatory regime. Professor Michael Messenger, head of regulatory strategy at the British In Vitro Diagnostics Association (Bivda), says his members “wholeheartedly welcome” this step towards greater regulatory transparency.
“It is essential for the effective planning and preparation of our members,” he remarks. “The medical diagnostics industry values regulatory certainty, predictability, clear and consistent timescales, consistent communication, and opportunities to engage with the regulator. The MHRA’s roadmap, in our view, outlines the agency’s intention to address these aspects, proposing a sensible and forward-thinking approach to reforming the UK’s regulations.”
How the changes will look in practice
So what’s driving the need for reform? Well, the UK already has a regulatory framework for medical devices, in the shape of the Medical Devices Regulations (MDR) 2002. However, 2002 was a very different time, and the regulations have since undergone several rounds of amendments. Some of these were designed to reflect changes in the corresponding EU laws. Others came in after Brexit, with a view to cutting ties with European institutions and bringing certain elements under UK jurisdiction.
The changes proposed by this roadmap are more extensive. In 2021, the government passed the Medicines and Medical Devices Act, which required the MHRA to undertake a full public consultation around what came next. The consultation found strong support for regulatory reforms, not least strengthening post-market surveillance requirements; improving the traceability of medical devices; introducing new routes to market and bringing in some clarity around software as a medical device (SaMD).
Since the findings were published, the MHRA has been working on turning the recommendations into law. The first example was a statutory instrument (SI) implemented last summer, which supports the transition from EU CE marking to United Kingdom Conformity Assessed (UKCA). As of July 2024 (postponed from July 2023) new devices will need a UKCA marking to be accepted on the British market. However, older CE-marked medical devices will still be permitted for up to five years as part of the transition process.
“This presents an opportune interval for manufacturers to meticulously prepare and re-evaluate their regulatory strategies,” comments Ana Méndez García, senior content specialist medical devices, regulatory intelligence, at Clarivate. “Proactively engaging in this process will position manufacturers ahead of their counterparts in the industry.”
As detailed in the roadmap, the next SI will look at post-market surveillance. This will include new requirements for manufacturers, including more stringent reporting obligations, and will apply from the end of 2024.
It will be followed by another SI around the MHRA’s ‘core’ regulations – 11 different areas ranging from clinical investigations to quality management systems to unique device identification. The agency plans to discuss these topics with stakeholders in the first half of 2024. Messenger at Bivda commends the MHRA’s willingness to engage with industry, as well as its emphasis on clear guidelines and timelines. “Early feedback from our members has been positive, with many expressing appreciation for the clarity and direction the roadmap provides,” he adds. “However, they are keen to see further details around the specific areas and initiatives. This feedback underscores the industry’s eagerness for a regulatory framework that not only safeguards public health but also supports growth and innovation.”
Emerging technologies
One notable feature of the roadmap is its focus on AI and SaMD. This is a broad category running the gamut from apps that measure a patient’s heart rate, to software that helps radiologists with image post-processing and analysis. It’s also a category in which regulation is mostly lacking.
“While there is vast potential for AI and machine learning to significantly improve healthcare outcomes in various ways, guidance around the use of these powerful tools is obviously needed,” explains Chan-Tsui. “AI use cases in medtech are tied to major implications – patients’ lives are at stake, after all – so the considerations in regulating these tools may look different from other sectors where the use cases don’t have the same kind of impact.”
In other words, regulators need to pay very close attention to the complex balance of factors at play in medtech. And if there are a few different agencies involved here (say one focusing on AI and one on medical devices), they certainly need to make sure they communicate.
Here, the AI Act in the EU could serve as a cautionary tale. According to Méndez García at Clarivate, its restrictive human oversight requirements could end up clashing with the EU’s medical device regulations around safety and performance. “Following the proposed AI Act EU, conformity assessments of AI medical devices will take manufacturers three times longer than in the US, so EU patients will be blocked access to certain innovative AI medical devices,” she says.
For its part, the MHRA has noted that “the majority of change required in this area is likely to be in the form of guidance rather than legislation”. Already, three SaMD guidance documents have been published, and at least three more are expected for 2024–25. The agency is also planning on launching a ‘regulatory sandbox’ called AI-Airlock – a virtual platform in which AI developers can generate regulator-friendly data for their products.
“By moving beyond conventional product concepts and associated regulations, sandboxes like the AI-Airlock offer a unique and safe learning space for manufacturers to work with regulators and other parties to explore new, cutting-edge solutions to help resolve these challenges,” said Dr Paul Campbell, MHRA head of software and AI, when the initiative was first announced.
Lofty goals
Another striking feature of the roadmap is its emphasis on international harmonisation. The goal is not only to encourage innovation domestically, but also to give UK-based businesses the best chance of expanding their global presence.
As the MHRA noted in one of its guidance documents: “We are sensitive to the fact that regulatory innovation that departs from international consensus can create an additional burden for the market.” It has said it will redouble its contribution to groups such as the International Medical Device Regulators Forum (IMDRF) and speed up routes to market for products that conform to comparable regulatory regimes.
With goals like this in mind, the roadmap is nothing if not ambitious. And while a lot has been accomplished already, the biggest changes are still to come. By the end of 2025, the UK’s medical device manufacturers will be looking to navigate a very different regulatory landscape – hopefully one that better reflects the world we’re in today.
“We are encouraged by the roadmap and optimistic about the positive impact these changes will have on our members and the broader healthcare landscape in the UK,” says Messenger at Bivda. “Its commitment to maintaining a balance between stringent safety measures and encouraging the introduction of new, innovative medical devices to the UK market is particularly notable. This equilibrium is vital for advancing healthcare outcomes for patients and ensuring that the UK remains at the forefront of medical device innovation.”
