Asked by: Caroline Dinenage (Conservative - Gosport)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Answer of 23 June 2023 to Question 189729 on Medicines and Healthcare products Regulatory Agency, whether she plans to initiate a priority review for medical devices.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
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:
https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy
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.
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.
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.
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.
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.
Asked by: Caroline Dinenage (Conservative - Gosport)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether (a) the Medicines and Healthcare products Regulatory Agency and (b) NICE will prioritise the regulatory timelines for medical devices that (i) respond to conditions outlined in the Major Conditions Strategy and (ii) where there is unmet need.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
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:
https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy
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.
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.
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.
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.
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.
Jan. 31 2024
Source Page: MHRA announces two new UK Approved Bodies to certify medical devicesFound: MHRA announces two new UK Approved Bodies to certify medical devices
Feb. 29 2024
Source Page: Medicines and Medical Devices Act report 2024Found: Medicines and Medical Devices Act report 2024
Apr. 30 2024
Source Page: Impact of AI on the regulation of medical productsFound: Impact of AI on the regulation of medical products
Asked by: Caroline Dinenage (Conservative - Gosport)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she plans to develop a Priority Review programme for medical devices.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
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:
https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy
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.
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.
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.
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.
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.
Jan. 09 2024
Source Page: Regulatory Roadmap points the way ahead for new measures to support safe access to medical technology including AI and diagnosticsFound: Regulatory Roadmap points the way ahead for new measures to support safe access to medical technology
Apr. 30 2024
Source Page: MHRA’s AI regulatory strategy ensures patient safety and industry innovation into 2030Found: MHRA’s AI regulatory strategy ensures patient safety and industry innovation into 2030
Apr. 24 2009
Source Page: Medicines and Health Care Products Regulatory Agency (MHRA) business plan for 2009-10. 34 p.Found: Medicines and Health Care Products Regulatory Agency (MHRA) business plan for 2009-10. 34 p.
Mar. 11 2024
Source Page: MHRA response to Equity in Medical Devices: Independent ReviewFound: MHRA response to Equity in Medical Devices: Independent Review