Regulatory
The UK’s new Regulatory Innovation Office aims to streamline approvals, support life sciences innovation, and help AI and digital health solutions reach the market more efficiently.
On top of that, it isn’t wholly clear how the RIO will be funded. A recent industry report has argued that the UK Medicines and Healthcare products Regulatory Agency (MHRA) needs more resources, with its “capacity and predictability” cited as major deterrents for investors. Meanwhile, the UK government has been explicit about the ‘black hole’ in public finances.
“The fear is that without cash, RIO will become another talking shop,” comments Rudd-Clarke. “If it ends up as a committee with limited resources, but one that must be consulted, it could even slow down the government’s efforts to reform regulations to boost the economy.” Though in theory, the RIO will perform a vital role. It will enable approval processes to be streamlined, provide pre-application support, and create regulatory sandboxes for testing new developments under regulatory supervision. Sandboxes are controlled environments where innovators can test out new approaches without some of the usual rules applying. It will also work to update regulations and speed up timeframes where appropriate. That will mean working in partnership with the MHRA – and possibly pushing back on some of their recommendations. For instance, it might suggest that regulators adopt more stringent safety monitoring once the products are already on the market, as opposed to creating more red tape during the approvals process. “RIO could ask whether new regulations are necessary, or whether they could be watered down to promote innovation by making the compliance burden cheaper,” suggests Rudd-Clarke. “It’s notable that the MHRA appears to be singing from the same hymn sheet, stating that it wants to support innovation whilst promoting patient safety.”
Making life science a priority There are certainly encouraging signs in this regard. In 2024, the MHRA created a regulatory sandbox for AI-based medical devices, known as AI Airlock. Five novel medical devices are being tested as part of the scheme, including a device that predicts health outcomes for lung disease, and another that makes cancer care more efficient. The agency is also pushing forward changes to medical device regulations, with a new UK medical device framework expected in draft form later this year. Historically, the UK has tended to update its regulations in line with the EU framework, but it’s possible that things could be different this time around. Rudd-Clarke notes that the RIO may end up “pushing for a lighter touch”. “The economic prospects in the EU look less promising than other jurisdictions, practically by the day,” he adds. “There has also been an increase in criticism of the EU regulatory model, such as the Draghi report that criticised the EU for over- regulating the market. The early pronouncements by RIO on whether or not the EU model will be followed will be fascinating to see.” Whatever happens, it’s clear that technological advancements in the life sciences sector are a government priority. As Lundy explains, the establishment of the RIO constitutes a strong sign of intent, even if the practical details remain hazy. Should its goals come to pass, device makers may soon find themselves operating within a more supportive regulatory environment. “It exemplifies how the government intends to boost the UK life sciences sector, making it an attractive environment for businesses to bring their innovative products to market,” says Lundy. “It’s a positive step towards enhancing the UK’s regulatory capability, supporting innovation, and driving investment and growth in the UK.” ●
Medical Device Developments /
www.medicaldevice-developments.com 21
3rdtimeluckystudio; ThomasLENNE/
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