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FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 30 Oct)

FDA Establishes New Advisory Committee on Digital Health Technologies The US FDA have formed a new Advisory Committee on Digital Health Technologies (DHTs) to help address different issues related to DHTs such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The committee will also advise the FDA on these issues, providing…
admin
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…
admin
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…
admin
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…
admin
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…
admin
November 3, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

TEAM-NB Notified Bodies call to action to manufacturers to apply

Team-NB hve published a press release "TEAM-NB Notified Bodies call to action to manufacturers to apply. October 2023" This press release is a call to action to to apply with notified bodies in time especially for high-risk IVD medical devices. It intends to raise awareness with the device manufacturers and other economic operators to apply with notified bodies in time.…
admin
October 27, 2023
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