Regulatory
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.”
Medical Device Developments /
www.nsmedicaldevices.com
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
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