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IMDRF publishes “In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)”

On 25 June, the IMDRF published their updated "In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)." This document sets out significant revisions based on regional policy changes since the last update was published in 2019. The table of contents is designed to support IVD regulatory submissions. IMDRF have confirmed that companion diagnostics are in scope but clinical…
admin
June 25, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UKHSA weekly update (WC 17 Jun)

Please note this is an extract of the original bulletin. Antimicrobial intravenous-to-oral switch: criteria for prompt switch Page summary: National antimicrobial intravenous-to-oral switch (IVOS) criteria for prompt switch​ have been developed for adult and paediatric patients, categorised into 5 sections. Change made: Added decision guide for paediatrics.
admin
June 25, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 10 Jun)

Please note this is an extract of the original bulletin. Software and artificial intelligence (AI) as a medical device Page summary: Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD). Change made: Updated guidance to include reference to guiding principles on transparency for machine learning-enabled medical devices…
admin
June 19, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 10 Jun)

Please note this is an extract of the original bulletin. UK-New Zealand Joint Committee ministerial statement Page summary: Details of the Joint Committee held as part of the United Kingdom-New Zealand Free Trade Agreement on 8 May 2024. Change made: First published. Export control licensing management information for Israel Page summary: Export control licensing management information from 7 October 2023…
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June 19, 2024
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