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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
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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
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: GB active substance renewal submission deadlines

Apply for active substance renewal by the deadlines to keep products on the GB market. Under the GB Biocidal Products Regulation (GB BPR), active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date. The 550-day deadlines are coming up for the following active substance/product type combinations under GB BPR: 27 December…
Ben Kemp
September 25, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Get ready for the biggest change to UK patent services

Get ready for the biggest change to UK patent services Big changes are coming to UK patent services, and we want to make sure you're fully prepared. Our new ‘One IPO Patent Service’ is launching in early 2026 transforming how you apply for and manage all your UK patents. To help you prepare for this major transition, we're publishing a…
Ben Kemp
September 25, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care Updates – WC 22 Sept

Health Secretary speech to British Medical Association Page summary: The Secretary of State for Health and Social Care spoke at the special meeting of the British Medical Association’s (BMA) representative body this morning. Change made: First published. Time updated: 9:51pm, 14 September 2025 Enabling pharmacist flexibilities when dispensing medicines Page summary: This consultation seeks views on proposals to enable pharmacist…
Ben Kemp
September 25, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates – WC 22 Sept

Export: APHA animal disease testing Page summary: Use this form to submit samples from animals for laboratory testing to meet the requirements for an export health certificate. Change made: Updated the guidance under the ‘Fast track service’ heading. Time updated: 3:07pm, 15 September 2025 APHA Weybridge: general testing form (LSW008) Page summary: Submit samples to the Animal and Plant Health…
Ben Kemp
September 25, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates – WC 22 Sept

US financial giants boost UK investments and jobs across London, Edinburgh, Belfast and Manchester Page summary: The Government has announced over £1.25 billion of inward investment from US finance companies, creating 1,800 UK jobs. Change made: First published. Time updated: 10:45pm, 13 September 2025 International Trade Week 2025 announced to get businesses exporting and grow the economy Page summary: Government…
Ben Kemp
September 25, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Environment, Food & Rural Affairs Updates – WC 22 Sept

Export: APHA animal disease testing Page summary: Use this form to submit samples from animals for laboratory testing to meet the requirements for an export health certificate. Change made: Updated the guidance under the ‘Fast track service’ heading. Time updated: 3:07pm, 15 September 2025 APHA Weybridge: general testing form (LSW008) Page summary: Submit samples to the Animal and Plant Health…
Ben Kemp
September 25, 2025