Regulatory
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.
While technology is a great enabler of health, it must also be balanced by regulatory oversight to ensure patient safety.
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
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“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.” ●
Medical Device Developments /
www.nsmedicaldevices.com
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