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UK Government Updates Regulatory Affairs Newsletter

UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers

The MHRA is to launch a regulatory sandbox- AI-Airlock to support the development of AI services in improving diagnoses, treatment selections and providing enhanced personalised care for patients. This regulatory sandbox aims to accelerate the development and deployment of software and AI medical devices, safely providing patients with earlier access to cutting edge innovations that improve care. The AI-Airlock will be…
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November 3, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 23 Oct)

Please note this is an extract of the original bulletin. Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles Page summary: Guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes. Change made: First published. MHRA and international partners publish five guiding principles for machine learning-enabled medical devices Page summary: The Medicines…
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November 3, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 23 Oct)

Please note this is an extract of the original bulletin. Smarter regulation and the regulatory landscape Page summary: Call for evidence on what works and what could be improved across the landscape of UK regulators. Change made: Link to response form also added under ‘How to respond’ in the call for evidence overview document. UK-Japan Critical Minerals Memorandum of Cooperation…
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November 3, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Gov.uk policy papers update (WC 23 Oct)

Please note this is an extract of the original bulletin. Consistency in household and business recycling in England Page summary: Seeking views on our plans to increase the consistency in materials collected for recycling in England. Change made: We have uploaded a new version of the Summary of consultation responses report (PDF). An earlier version of this report incorrectly stated…
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November 3, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 23 Oct)

Please note this is an extract of the original bulletin. Expert regional innovation hubs given £75 million boost to local research, businesses and economies across UK Page summary: Regional clusters of innovation across the UK backed by £75 million that will boost local economies and pioneer game-changing solutions from healthcare to net zero. Change made: First published. Research Ventures Catalyst…
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November 3, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA and international partners publish guiding principles for machine learning-enabled medical devices

MHRA, U.S. Food and Drug Administration (FDA) and Health Canada have jointly released 'Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles' In this document, MHRA, FDA and Health Canada have jointly identified 5 guiding principles for predetermined change control plans (PCCP). These principles draw upon the Good Machine Learning Practice (GMLP) guiding principles. PCCPs provide a new…
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October 27, 2023
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