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Regulatory Affairs Newsletter Archive

Join the Next R&D Leaders Circle on June 26! Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Join the Next R&D Leaders Circle on June 26!

The MDIC-Deloitte R&D Leaders Circle Returns June 26! Join us at our next gathering of the MDIC-Deloitte R&D Leaders Circle, a unique community of practice for seasoned and emerging leaders in medical device Research and Development and Project and Portfolio Management. Our next virtual meeting will include a dynamic panel discussion exploring how AI is transforming MedTech innovation and product development.…
Ben Kemp
June 9, 2025
IP Connect: Exclusive insights from Washington talks and latest policy updates from the UK Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

IP Connect: Exclusive insights from Washington talks and latest policy updates from the UK

London to host world's largest IP event in 2026 The UK's global leadership in IP has been recognised with the announcement that the International Trademark Association (INTA) will hold its 148th Annual Meeting in London from 2-6 May 2026. This prestigious event – the largest gathering of IP professionals and brand owners worldwide – is expected to attract more than…
Ben Kemp
June 9, 2025
Update: culture media and antibodies subject to additional Border Inspection Post controls European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Update: culture media and antibodies subject to additional Border Inspection Post controls

Please see below update from Medtech Europe regarding the proposal to include new CN codes in the EU Animal By-products legislation. See also the EC response to the issues posed by MedTech Europe. Please note that these requirements will also impact shipments from GB to Northern Ireland, as well as shipments from third countries to Northern Ireland, and shipments from…
Ben Kemp
June 9, 2025
APHA – Border Trade Newsletter – getting it right at the border 29-05-25 Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA – Border Trade Newsletter – getting it right at the border 29-05-25

Getting it right at the border  This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: Some of the messages in this edition were originally sent last week, However, they remain…
Ben Kemp
June 9, 2025
MHRA Safety Roundup: May 2025 Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MHRA Safety Roundup: May 2025

Note that MHRA have issued the below notice regarding Biotin Interference with Thyroid Function Tests (Immunoassays). FDA had previously issued guidance regarding this topic Testing for Biotin Interference in In Vitro Diagnostic Devices | FDA. Although MHRA have specifically highlighted the issue with TFT tests, manufacturers should consider Biotin interference with their Immunoassays more generally. MHRA have an ongoing consultation…
Ben Kemp
June 9, 2025
FDA Consensus Standards FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus Standards

FDA have updated the consensus standards- as at 26/05/2025. For the degree of recognition click on the recognition information column - Recognized Consensus Standards: Medical Devices This includes many CLSI updates for IVDs including some software aspects. Below are just the IVD updates. 05/26/2025 InVitro Diagnostics 7-328 Partial CLSI M100 35th Edition Performance Standards for Antimicrobial Susceptibility Testing   05/26/2025…
Ben Kemp
June 9, 2025