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Ben Kemp

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
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