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Regulatory Affairs Newsletter Archive

Emerging Roadmap and transition provisions – Government MedRegs blog Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Emerging Roadmap and transition provisions – Government MedRegs blog

A new post, “Emerging Roadmap and transition provisions” has just been published on the MedRegs blog. Read the new post: https://medregs.blog.gov.uk/2024/11/01/emerging-roadmap-and-transition-provisions/
Ben Kemp
November 6, 2024
CLSI October Newslettter Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CLSI October Newslettter

Members may be interested in updates on: the transfer of CLSI EP37 Supplemental Information on Exogenous substances to an online database, the upcoming webinars, the Introduction of CLSI AUTO11 - Information Technology Security of In Vitro Diagnostic Instruments and Software Systems, 3rd Edition. You can find the newsletter here.
Ben Kemp
November 6, 2024
Online course: TOPRA IVD Regulatory Affairs for Global Markets Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Online course: TOPRA IVD Regulatory Affairs for Global Markets

TOPRA’s Regulatory Affairs for Global Markets course takes place on 19-20 November and will be co-chaired by BIVDA’s Chair of the Regulatory Affairs Working Party, Stuart Angell, and BIVDA alumni, Ashleigh Batchen, now of TUV SUD. This two-day CRED course will cover the latest updates in globalmarkets including the US, Canada, China and Brazil and will also address key areas…
Ben Kemp
November 5, 2024
MHRA Update (WC 28 Oct) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update (WC 28 Oct)

Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled. Change made: Removed DEU/002/2021/001 (Numed Inc) & DEU/001/2024/001 (Inspire Medical Systems, Inc.) from Open list.Added DEU/001/2024/001 (Inspire Medical Systems, Inc.) to Closed list. Time updated:…
Ben Kemp
November 1, 2024