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MHRA Medical Devices Regulatory Reform: Roadmap to implementation

The MHRA has published a revised roadmap, providing a further update on the intended timelines to implement the future medical device regulations. This new revision provides updates in four key areas, along with associated milestones and expected timelines for each. Please see here for more information.
Ben Kemp
December 18, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

BTOM update – getting it right at the border

New import controls were implemented on 30 April 2024. This email gives you operational information on the Border Target Operating Model (BTOM). Common Health Entry Documents – Good Practice to reduce delays Estimated Time of Arrival (ETA) in IPAFFS Resources to help you comply Contact points for urgent BTOM queries Common Health Entry Documents   What is a CHED?  A Common…
Ben Kemp
December 16, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Notifying BSI of Changes to PMCF and PMPF plans

Critical Communication Notifying BSI of Changes to the Post-market Clinical Follow-up (PMCF) and Post-market Performance Follow-up (PMPF) Plans There is currently a lack of guidance on what constitutes a substantial change to a PMCF/PMPF plan. To address this gap and to provide clarity for our clients, BSI has issued this communication setting out our expectations. For MDR and IVDR devices…
Ben Kemp
December 16, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 9 Dec)

AI Airlock pilot cohort Page summary: An overview of the five technologies selected for the AI Airlock pilot. Change made: First published. Time updated: 9:00am, 4 December 2024 MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach Page summary: The pilot scheme, AI Airlock, is designed to help test and improve the rules for…
Ben Kemp
December 16, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates (WC 9 Dec)

DMCCA 2024: turnover and control regulations Page summary: Consultation on draft legislation to be made under powers provided for by the Digital Markets, Competition and Consumers Act (DMCCA) 2024 regarding turnover and control. Change made: List of respondents added to consultation response. Time updated: 4:56pm, 2 December 2024 New plans revealed to save small firms £22,000 a year and improve…
Ben Kemp
December 16, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care Updates (WC 9 Dec)

Improving integrated commissioning in health and social care Page summary: We want your views on changes to section 75 of the NHS Act 2006 to increase the use of pooled budgets to support the integration of health and care. Change made: Added summary of responses report. Time updated: 12:47pm, 3 December 2024 Excess treatment costs (ETCs) in non-commercial research Page…
Ben Kemp
December 16, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Updates (WC 9 Dec)

Office for Product Safety and Standards Horizon Scan 1.0 Page summary: A research report on future and emerging technologically driven changes relevant to OPSS. Change made: First published. Time updated: 11:43am, 3 December 2024 EU Regulation 2023/988 on General Product Safety Page summary: Guidance for Market Surveillance Authorities. Change made: First published. Time updated: 2:59pm, 3 December 2024 General product…
Ben Kemp
December 16, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 9 Dec)

Maps of Freeports, Freeport customs sites and Freeport tax sites Page summary: This collection brings together a list of Freeport maps, Freeport customs site and Freeport tax site locations legislated for within them, and a statement on the designation process. Change made: Maps of Anglesey Freeport tax sites added. Time updated: 2:12pm, 3 December 2024 Maps of UK Freeports Page…
Ben Kemp
December 16, 2024
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