NEWS
New legislation sets out reform for regulation of medical devices
New legislation will introduce clearer and risk-proportionate requirements that improve the safety of medical devices across Great Britain and provide certainty for manufacturers ahead of introducing the wider future regulatory regime. The Post-market Surveillance (PMS) Statutory instrument (SI) laid in Parliament on 21 October is the first major update to the framework of medical device regulations in Great Britain, led by the Medicines and Healthcare products Regulatory Agency (MHRA).
In 2021, the MHRA consulted on the
‘Future Regulation of Medical Devices in the UK’ in response to recommendations set out in the Independent Medicines and Medical Devices Safety (IMMDS) review, published in 2020. Responses to the consultation were strongly supportive of introducing clearer and more robust PMS requirements to improve patient and public safety and called for closer alignment with international approaches. Since January 2021 all medical devices have been required to be registered with the MHRA before they can be placed on the market in Great Britain a step change in the Agency’s oversight of medical devices, allowing it to take more rapid action where safety concerns are identified. By introducing clear, risk-proportionate
requirements, the new legislation will build on measures already introduced to improve patient safety, facilitating greater traceability of incidents and reporting trends. This regulation also ensures that the UK has a strong foundation for patient safety in place before MHRA brings forward future measures such as international reliance which will allow patients to benefit more quickly from some types of medical devices that have already been approved for use in other countries. The MHRA is committed to delivering a framework of regulatory reform that encourages innovation and growth in life sciences and which, in turn, brings huge benefits to patients. The SI proposes a six-month
implementation period once Parliamentary processes have been concluded. This regulation could, therefore, become law in summer 2025.
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Helping to detect antibiotic resistance using AI
Researchers at the University of Zurich (UZH) have used artificial intelligence (AI) to help identify antibiotic- resistant bacteria. The team led by Adrian Egli, UZH professor at the Institute of Medical Microbiology, is the first to investigate how GPT-4, a powerful AI model developed by OpenAI, can be used to analyse antibiotic resistance. The researchers used AI to interpret a common laboratory test known as the Kirby-Bauer disk diffusion test, which helps doctors to determine which antibiotics can or can’t fight a particular bacterial infection. Based on GPT-4, the scientists created the ‘EUCAST-GPT-expert’, which follows strict EUCAST (European Committee on Antimicrobial Susceptibility Testing) guidelines for interpreting antimicrobial resistance mechanisms. By incorporating the latest data and expert rules, the system was tested on hundreds of bacterial isolates, helping to identify resistance to life-saving antibiotics. Pictured is an example of the Kirby- Bauer disk diffusion test of gut bacteria.
Paper sheets soaked with antibiotics are placed on a petri dish. The antibiotic concentration decreases with increasing distance. The closer bacteria grow to the test sheets, the more resistant they are (red circles). If the gradients of two different antibiotics meet, their
effectiveness can increase (yellow arrows). The AI system performed well in detecting certain types of resistance, but it wasn’t perfect. While it was good at spotting bacteria resistant to certain antibiotics, it sometimes flagged bacteria as resistant when they were not, leading to possible delays in treatment. In comparison, human experts were more accurate in determining resistance, but the AI system could still help standardise and speed up the diagnostic process. n Giske CG, Bressan M, Fiechter F, et al. GPT-4-based AI agents-the new expert system for detection of antimicrobial resistance mechanisms?. J Clin Microbiol. Published online October 17, 2024. doi:10.1128/jcm.00689-24
New £5 million accelerator to support UK MedTech innovation
CPI, a leading technology innovation centre, and the Office for Life Sciences (OLS) have joined forces to deliver the MedTech Accelerator: Rapid Regulatory Support Fund (MARRS), a £5 million programme funded by UK Government aimed at supporting and enabling growth in the vital UK MedTech industry. The new MARRS fund is designed to help start-ups and SMEs access essential regulatory advice. Companies can apply now for a grant of up to £30,000 to fund external regulatory guidance and support, helping them accelerate the development of new, safe and effective devices to market or keep critical devices available to patients in compliance with new regulatory requirements. SMEs are encouraged to submit applications as soon as possible. The project will also aim to accelerate transformative medical technologies
by identifying major technology and investment opportunities and proposing initiatives to unlock investment, skills and capacity. In addition to the grant funding programme, CPI will continue to work with the MedTech industry to understand and identify current challenges that can be solved by collaborative public, academic and industry partnerships. In October last year, CPI called for an
urgent MedTech industrial strategy to be established to stop the UK from falling behind in the rapidly growing global MedTech industry. The organisation published two reports, which warned that unless the Government steps in to support the sector, the UK could lose out on highly skilled jobs and billions of pounds in revenue. More information at:
https://www.uk-cpi. com/medtech-accelerator-rapid-regulatory- support-marrs-programme
DECEMBER 2024
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