Life Sciences Council Joint Statement on Medical Devices Regulatory Reform
The reform of the UK’s Medical Device regulation offers a golden opportunity to drive innovation and growth in the UK’s Life Science sector while ensuring patient safety remains at the heart of the regulatory approach. But there is an urgent need for action to ensure we do not lose 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) have today announced a new agreement to accelerate the delivery of the future UK HealthTech regulatory system. Acknowledging the Chancellor’s priorities of stability and growth supported by regulatory reforms, and the importance of the success of the system to UK patients and the Life Science sector, they have formed an advisory group on behalf of the Life Sciences Council to drive the delivery of the ambition of the Life Sciences Vision to have a best in class regulatory system.
The advisory group has agreed that aligned proposals will be published on three priority areas: international recognition; routes for innovation; and system capacity. Initial proposals will be published in February 2023. Joint working in these areas will support the delivery of a system that protects patient safety whilst accelerating access to innovative technologies. The proposals will define how policy concepts such as the use of e-labelling and recognising the approvals of other trusted jurisdictions, such as the US, could work in practice to reduce burden on industry and release resource 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 sustainability and delivery of the NHS Net Zero targets.
The MHRA will also publish a comprehensive UK roadmap of activities, milestones and timelines to deliver the required regulatory infrastructure. Any timelines will ensure sufficient time to allow the regulators and industry to prepare.
This agreement, which emerges from the Life Sciences Council, strengthens engagement with a full range of stakeholders and establishes regular updates throughout the development and delivery process. It supplements the ongoing engagement through the existing regulatory framework implementation programme, the Trade Association / MHRA liaison forum, and the full spectrum of focus groups that will now begin work. In addition, the ABHI will work to collate industry-wide input with other trade associations and to provide further industry expertise, to consult with and support the regulator, throughout the delivery of the new regulatory arrangements.