UK government to invest more in medical devices regulatory capacity

The government has pledged to increased investment, targeting in particular the bodies that can approve medical devices and ensure their conformity with new regulatory requirements. It is an important move to address anticipated capacity restraints as the government is in the process of implementing changes to the regulatory framework for medical devices in the UK, according to legal expert Louise Fullwood of Pinsent Masons.

The announcement forms part of the government’s response to an independent report by the Regulatory Horizons Council (RHC), which set out recommendations on the future regulation of medical devices following UK’s exit from the European union. The government’s response focuses on the recommendations that it will take on board while preparing for the implementation of the future Medical Device Regulations by July 2024.

The government has accepted in principle one of the RHC’s recommendations: to strengthen and increase funding to the Medicines and Healthcare products Regulatory Authority (MHRA), and so significantly expand the regulator’s capacity in medical devices, including in approving and regulating emerging technologies.

“This [increased regulatory capacity] will help break through bottlenecks in getting new products certified. It should also create new jobs in a highly skilled profession; we have some excellent regulators and engineers who could take on these roles,” said Fullwood.

There have already been proposals for changes to the MHRA’s statutory fees, which aim to ensure the MHRA is adequately resourced, including in areas of technological progress in medical devices where increased resource is required.

The RHC, in its report, highlighted the shortage of UK approved bodies (AB) for conformity assessment and the bottlenecks in the approval of medical devices as two of the main issues currently facing patients, and manufacturers and suppliers of medical devices.

The government intends to address these capacity challenges by increasing the number of UK ABs and through mitigation measures, for example allowing manufacturers to leverage certification under the existing  UK Conformity Assessed (UKCA) or EU CE conformity marking processes.

The government said that the MHRA is currently reviewing several applications from organisations that have applied for UK AB designation. The regulator is also actively working with organisations that are preparing to apply for designation either through new applications or extending their existing scope for conformity assessment.

In mitigation measures, the government will adopt a phased approach to introducing conformity marking requirements under the UK’s future regulatory framework for medical devices. Devices that are UKCA marked under the existing UK regulations prior to the new regime taking effect from 1 July 2024 will be permitted to continue to be placed onto the domestic market for between three to five years depending on use or until their current certifications expire, whichever is sooner. Devices that are CE marked under EU legislation will be given similar transition timescales when the new regime comes into effect.

The government has also accepted in principle a recommendation to invest in the UK as a global centre for regulatory science and the training of regulatory professionals with expertise in medical devices, including emerging technologies, in line with its ambition of turning the UK into a leading global hub for life sciences.

One of its proposed methods of achieving this is through specific funding to the MHRA and the National Institute for Health and Care Excellence (NICE) to develop a new access and licensing pathway for medical devices, similar to that which exists for medicines. Another proposal will introduce new regulatory requirements on manufacturers to have at least one person who has the requisite qualifications and regulatory experience within their organisations.