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Regulatory Affairs Newsletter

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DHSC Updates – WC 30 Sept

AI to be trialled at unprecedented scale across NHS screening Page summary: Pioneering new cloud computer system will allow AI tools to be tested on an unprecedented scale across the NHS to boost early diagnosis Change made: First published. Time updated: 3:41pm, 22 September 2025 Antimicrobial resistance (AMR) Page summary: Information and resources on the UK’s plans to see antimicrobial…
Ben Kemp
October 2, 2025
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 30 September

Designated standards: radio equipment Page summary: Notices of publication and a consolidated list for designated standards for radio equipment. Change made: Notice of publication amended and consolidated list updated. Time updated: 12:05am, 25 September 2025 Designated standards: machinery Page summary: Notices of publication and a consolidated list for designated standards for machinery. Change made: Notice of publication amended and consolidated…
Ben Kemp
October 2, 2025
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New guidance and tools for GOV.UK sanctions content

Note that although IVDs are typically not themselves subject to restrictions under sanctions unless possibly considered to be dual use, or contain cryptography technology to encrypt patient data (in which case export licences are required). Some organisations offering services related to export or finance maybe restricted or be reluctant to be involved in exports to sanctioned countries. E.g. legal services…
Ben Kemp
October 2, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Border Trade Newsletter – getting it right at the border 26 09 25

Getting it right at the border  This newsletter 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: STORM incident hub HMRC System Maintenance on CDS GOV.UK One Login enabled Foot and Mouth Disease in Hungary Useful contacts and information STORM…
Ben Kemp
October 2, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Now ‘Live’! Open Letter to EU Health Commissioner Olivér Várhelyi on IVDR and MDR

On 19 September 2025, together with 35 national associations, MedTech Europe has sent an open letter to European Commissioner for Health & Food Safety, Olivér Várhelyi, calling for urgent action to secure the availability of medical technologies for European citizens and health systems.
Ben Kemp
September 25, 2025
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Premarket to Postmarket: Navigate Global Cybersecurity Expectations with Confidence

Strategic Cybersecurity for Regulatory Success—Are You Aligned?   12 and 14 November 2025  •  9:00 AM - 5:00 PM ET  •  12.0 RAC Credits   Health authorities spanning the US, European Union, Australia, Canada, and Japan have issued cybersecurity guidance that is essential for regulatory affairs professionals to understand. In addition to premarket concerns, some of the guidance also includes…
Ben Kemp
September 25, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

UK NEQAS Microbiology and Parasitology webinar on POCT

UK NEQAS is holding a six-part pan-disciplinary webinar series Quality Standards in Point of Care Testing. The second webinar will take place on 1 October 2025 and registration is now open at https://us06web.zoom.us/webinar/register/WN_a1-uMaqNThitDqJ0F-k1OA The webinar will include the following presentations – Professor Peter L. Chiodini Malaria Antigen Rapid Diagnostic Tests, what a dipstick! With apologies to "Only Fools and Horses”…
Ben Kemp
September 25, 2025
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