Medical devices to get ‘early access’ to NHS under regulatory scheme

The ‘early access to innovative medical devices’ scheme is to be administered by the Medicines and Healthcare Regulatory Authority (MHRA). The regulator has published a statement of policy intent that details its “initial thinking” on how the scheme might operate.

According to the MHRA, the scheme will “offer conditional market access for innovative devices that address clearly defined unmet clinical needs from the NHS or that have the potential to significantly improve patient outcomes”. It added that it will “offer a bridging scheme to maintain patient access to devices where the clinical investigation has ended and the manufacturer is still awaiting regulatory approval”.

The MHRA has powers under UK medical device regulations to exempt devices from meeting certain regulatory requirements.

Details of how the scheme will operate have still to be finalised, but the MHRA said medical device manufacturers seeking to participate in the initiative will be able to pay a fee for regulatory advice on whether their device “qualifies” for the scheme. The MHRA added that “benefit-risk criteria will be communicated early to innovators enabling better planning and regulatory engagement”, together with "clear milestones” and “documentation expectations”.

Where accepted onto the scheme, manufacturers will gain “time-limited authorisation” to supply their product to the NHS, “with specific conditions to ensure ongoing safety monitoring, and data collection”, the MHRA said, adding that the companies will be “expected to demonstrate continued progress toward full regulatory approval during this period”.

The initial focus of the scheme will be on “innovative diagnostic devices, particularly those supporting the NHS’s most urgent needs and financial sustainability in the NHS”, the regulator said.

Catherine Drew and Gareth Morgan, experts in life sciences regulation at Pinsent Masons, welcomed the announcement of the scheme, but stressed the importance of tying it in with the system of approval and reimbursement overseen by NHS commissioning bodies in the UK, such as the National Institute for Health and Care Excellence (NICE) in England.

Drew said: “News of this early access scheme will be welcomed by medical device manufacturers and has the potential to make the UK a more attractive jurisdiction for bringing new products to market – in essence, it would provide a test ground for the latest technological innovations. However, in practice the success of the scheme will depend on ensuring MHRA and NICE are aligned, as otherwise the effort from MHRA is not going to have the widest possible benefit for patients.”

Morgan said the MHRA and NICE operate a joined-up approach in relation to the early access to medicines scheme the MHRA already administers in relation to pharmaceutical products. That scheme is part of the wider innovative licensing and access pathway (ILAP) introduced post-Brexit to accelerate the time it takes to bring new treatments to market and thereby facilitate patient access to innovative new medicines.

An equivalent innovative device access pathway (IDAP) also operates, under which the MHRA can enable medical devices that have not obtained UKCA or CE certification to be placed on the British market in the interest of the protection of public health under what is known as the Unmet Clinical Need Authorisation (UCNA) tool.

In its policy paper, the MHRA said the new early access scheme it is planning will “extend the use of the UCNA tool beyond innovative pathways such as IDAP, supporting broader innovation across the medtech sector.”

Morgan said: “Under the ILAP scheme, there is a joined-up approach between the MHRA and NICE from the outset, to ensure that innovative medicines actually reach patients and can continue to be given to patients.”

“The potential lacuna with the new scheme is where a device manufacturer is given an IDAP UCNA, but if the device is one that has the potential for NHS wide use, NICE then isn’t on board with a recommendation of the device. There has to be a connection between the MHRA authorising the device and NICE recommending its use in the NHS – in the pharmaceutical space, there can often be a disconnect between the two, meaning NHS patients often do not benefit from the innovation,” he said.