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<p>The Priority Review programme is not currently planned, but the Government is taking
other significant steps for medical device regulatory reform, as part of a broader
Medical Technology Strategy. Further information on the Medical Technology Strategy
is available at the following link:</p><p> </p><p><a href="https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy"
target="_blank">https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy</a></p><p>
</p><p>The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible
for regulating medical devices, and designates United Kingdom Approved Bodies to conduct
conformity assessments against the relevant regulatory requirements. The MHRA works
closely with Approved Bodies to ensure their timely assessment.</p><p> </p><p>Following
a consultation on the future regulation of medical devices in 2021, the MHRA is leading
a programme of work to introduce updated regulations for medical devices that prioritise
patient safety, improve patient access to innovative medical devices, and ensure the
UK remains an attractive market for medical technology innovators. In January of this
year, the MHRA published a MedTech Regulatory roadmap that sets out the main activities
in implementing the future regulations throughout 2024 and 2025. An international
recognition framework for medical devices will form part of the future regulatory
framework, which will provide an alternative route to the UK’s market, by leveraging
approvals from comparable international regulators. The MHRA aims to publish an outline
of the International Recognition Framework for medical devices later this spring,
aligned to the Life Sciences Council, subject to necessary approvals.</p><p>In addition,
the MHRA is leading the reform of the medical devices regulatory landscape and includes
a new pathway to accelerate access to safe, innovative medical devices to help meet
the unmet needs of patients. The Innovative Devices Access Pathway aims to bring new
medical technologies and solutions to the National Health Service, to support the
medical needs that are not currently being met. There are eight innovative medical
technologies included in the pilot phase.</p><p>We are working alongside others to
further the Life Sciences Vision, particularly improving regulation and regulatory
processes around medical devices, and supporting broader ambitions in the vision aligned
to the conditions set out in the Major Conditions Strategy. As we work to update the
medical devices regulatory landscape, the MHRA is taking the Major Conditions Strategy
into consideration, including the six groups of major health conditions.</p><p>The
National Institute for Health and Care Excellence (NICE) is not a regulator but makes
recommendations for the NHS on whether selected medical devices should be routinely
adopted by the NHS, based on an assessment of their costs and benefits. Medical devices
are prioritised for the NICE’s evaluation, in line with NICE’s published topic selection
manual.</p>
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