Life Sciences Council Joint Statement on Medical Devices Regulatory Reform

The UK medical device regulatory reform presents a golden opportunity to drive innovation and growth in the UK life sciences sector, while keeping patient safety at the heart of the regulatory approach. But there is an urgent need for action to ensure that we do not miss this opportunity. Senior members of the Life Sciences Council, Will Quince MP, Minister of State at the Department of Health and Social Care, Dr June Raine, CEO, Medicines and Healthcare products Regulatory Agency (MHRA) and Peter Ellingworth, CEO, Association of British HealthTech Industries ( ABHI) today announced a new agreement to accelerate the delivery of the future UK HealthTech regulatory system. Recognizing the Chancellor’s priorities of stability and growth, underpinned by regulatory reforms, and the importance of the system’s success for UK patients and the Life Science sector, they have formed an advisory group on behalf of the Life Sciences Council to review the provision of the ambition of the Life Sciences Vision to have a best-in-class regulatory system.

The Advisory Group agreed that aligned proposals will be published in three priority areas: international recognition; pathways for innovation; and system capacity. The first proposals will be published in February 2023. Working together in these areas will support the delivery of a system that protects patient safety while accelerating access to innovative technologies. The proposals will determine how policy concepts such as using e-labelling and recognizing the approvals of other trusted jurisdictions, such as the US, could work in practice to reduce burdens on industry and free up resources in the regulatory system . This resource can be used to develop and deliver innovative processes that exploit the opportunities offered by the Brexit freedoms. The group will also explore how the regulatory framework can support sustainability and the achievement of the NHS Net Zero targets.

The MHRA will also publish a comprehensive roadmap for the UK with activities, milestones and timelines to deliver the required regulatory infrastructure. Any timelines will ensure that there is sufficient time for regulators and the industry to prepare.

This agreement, which emanates from the Life Sciences Council, strengthens engagement with a range of stakeholders and ensures regular updates throughout the development and delivery process. It complements ongoing engagement through the existing regulatory framework implementation program, the Trade Association/MHRA Liaison Forum and the full spectrum of focus groups now underway. In addition, the ABHI will work to gather industry-wide input with other industry associations and to provide further industry expertise, to consult and support the regulatory body during the implementation of the new regulations.

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