A pioneering new partnership between Newcastle University, Newcastle Hospitals and the Medicines and Healthcare products Regulatory Agency (MHRA) will develop clear and comprehensive guidance on the regulation of neurotechnologies, designed to accelerate access to these cutting-edge devices for UK patients.
New neurotechnologies are improving our understanding of the human brain and treatment for neurological conditions. Realising the potential of neurotechnology to improve health, advance scientific discovery, and deliver economic benefit, requires strong regulation to support safe research, adoption and use.
The partnership will involve a full review of existing regulations and guidance for neurotechnologies, such as implanted brain-computer interfaces, neurostimulators and wearables, and will develop new guidance for emerging neurotechnologies. This will strengthen the UK’s capacity to rapidly and safely support current and next generation neurotechnology innovation.
Expertise and insight will be sought from stakeholders throughout the UK and global neurotechnology ecosystem, including people with lived experience, academics, clinicians, charities and industry.
The partnership is led by principal investigator, Dr. Luke Bashford, on behalf of Newcastle University and Newcastle Hospitals, and co-investigators Prof. Anne Vanhoestenberghe, Kings College London and Prof. Tim Denison, Oxford University.
Dr Luke Bashford said:
“We will ensure the regulatory pathway for translating neurotechnology innovation to widespread patient benefit is relevant, appropriate, and easily accessible to all stakeholders. It demonstrates the UK as a neurotechnology leader from first-in-human and research studies to pivotal and post-market clinical trials. It should be seen as a global invitation to advance neurotechnologies here in the UK.
Our team at Newcastle University and Newcastle Hospitals NHS Foundation Trust are proud to lead this truly collaborative project and deliver the outputs openly and equitably. This work demonstrates the community’s continued commitment to research and ensuring people can access the latest clinical care for neurological conditions.”
For more information about the partnership, to explore ways to be involved and/or contribute, please contact Dr Luke Bashford at [email protected].
Full MHRA media release is available here.
