Life Sciences Council Joint Statement on Medical Devices Regulatory Reform | Daily News Byte

Life Sciences Council Joint Statement on Medical Devices Regulatory Reform

 | Daily News Byte


The reform of the UK’s medical device regulation offers a golden opportunity to drive innovation and growth in the UK’s life sciences sector while ensuring patient safety remains at the heart of the regulatory approach. But we need to take immediate action to ensure that we don’t miss this opportunity. Senior members of the Life Sciences Council, Will Quince MP, Minister of State for Health and Social Care, Dr June Wren, CEO, Medicines and Healthcare Products Regulatory Agency (MHRA) and Peter Ellingworth, CEO, Association of British Healthtech Industries (ABHI) today. ​Future UK HealthTech has announced a new agreement to accelerate delivery of the regulatory system. Recognizing the Chancellor’s priorities of stability and growth, supported by regulatory reforms, and the importance of the system’s success for UK patients and the life sciences sector, they have formed an advisory group on behalf of the Life Sciences Council. Life Science Vision’s ambition is to be a best in class regulatory system.

The Advisory Group agreed that aligned proposals would be published on three priority areas: international recognition; avenues for innovation; and system capacity. Preliminary proposals will be published in February 2023. Joint work in these areas will support the delivery of systems that protect patient safety while accelerating access to innovative technologies. The proposals will define how policy concepts such as the use of e-labelling and recognition of approvals from other trusted jurisdictions such as the US, can work in practice to reduce the burden on industry and free up resources in the regulatory system. This resource can be used to develop and deliver innovative processes that seize the opportunities that Brexit freedoms provide. The group will also explore how the regulatory framework can support the sustainability and delivery of NHS Net Zero targets.

The MHRA will also publish a comprehensive UK roadmap of activities, milestones and timelines for delivering the necessary regulatory infrastructure. Any timeline would ensure sufficient time for regulators and industry to prepare.

The agreement, which emerged from the Life Sciences Council, strengthens engagement with the full range of stakeholders and establishes regular updates throughout the development and delivery process. It complements ongoing engagement through the full spectrum of the existing Regulatory Framework Implementation Programme, trade association / MHRA liaison forums and focus groups which will now commence work. In addition, ABHI will work with other trade associations to engage industry-wide input and provide greater industry expertise to consult and support the regulator during the delivery of new regulatory regimes.


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