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<p>The Medicines and Healthcare products Regulatory Agency (MHRA) is progressing reforms
to the Medical Devices Regulations 2002. These are outlined in the Government response
to the consultation on the future regulation of medical devices in the United Kingdom
published in June 2022.</p><p>On 9 January, the MHRA published a roadmap, which sets
out a clear path for the development of new and robust regulations for medical devices
over 2024 and 2025. The new regulations will put patient safety first, whilst enhancing
the United Kingdom’s position as a world-leading environment for medical technology
innovators.</p><p>In September 2023, the Department, in partnership with the MHRA,
the National Institute of Care Excellence, NHS England, Health Technology Wales and
Scottish Health Technology Group, launched the Innovative Devices Access Pathway pilot.
The pilot provides an accelerated pathway for innovative technologies that meet an
unmet need in the National Health Service, including regulatory and support to streamline
their adoption into the NHS.</p>
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