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Regulatory Affairs Newsletter Archive

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Only 6 weeks to go until BIVDA’s Regulatory Affairs Seminar

There are only 6 weeks until BIVDA's Regulatory Affairs Seminar 2026 returns on 10–11 February 2026 in Birmingham — and it promises to be the must-attend event for diagnostics regulatory professionals across the UK, Europe, and beyond. This year's theme is 'Think Locally, Act Globally', dedicating a day each to UK and international regulation to help attendees maximise opportunities and…
Ben Kemp
December 9, 2025
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

BIVDA/NN Translations Webinar: How to Work Effectively with Language Service Providers and Translators

Taking place on 16 December, 1:00 PM – 2:00 PM GMT, NN Translations Founder Nataliya Nedkova will host a webinar about one of the most challenging, often misunderstood areas of medical device and IVD regulatory compliance: translation workflows. What will the webinar explore? 🔹 The hidden challenges behind medical and regulatory translations 🔹 How to work effectively with LSPs and…
Ben Kemp
December 9, 2025
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Build a Stronger Lab: Strengthen Your Molecular Testing Systems

CLSI MM19 provides comprehensive recommendations for molecular diagnostic testing, that cover strategic planning, regulatory requirements, implementation, quality management, and special considerations for subspecialties of molecular genetics including infectious diseases, oncology, malignant hematology, and pharmacogenetics.
Ben Kemp
December 5, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update – WC 24 Nov

Multi-million pound backing for cutting edge projects by UK scientists and innovators Page summary: New government funding will help make the boldest ideas in UK life sciences a reality. Change made: First published. Time updated: 9:00am, 18 November 2025 Professor Alastair Denniston: The future regulation of AI in healthcare Page summary: Creating a framework that is safe, fast and trusted.…
Ben Kemp
December 5, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care – WC 24 Nov

Intellectual property (IP) guidance for the NHS in England Page summary: This guidance provides practical steps, good practice principles, case studies and model agreements and templates to support effective IP management in the NHS. Change made: First published. Time updated: 9:00am, 18 November 2025 Multi-million pound backing for cutting edge projects by UK scientists and innovators Page summary: New government…
Ben Kemp
December 5, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology – WC 24 Nov

Engineering Biology Sandbox Fund: successful projects Page summary: This fund supports innovative engineering biology sandboxes which aim to accelerate pro-innovation regulatory reform and encourage business innovation and investment. Change made: Round 2 successful project announced. Time updated: 9:00am, 18 November 2025 Engineering Biology Sandbox Fund Page summary: This fund supports innovative engineering biology sandboxes which aim to accelerate pro-innovation regulatory…
Ben Kemp
December 5, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates – WC 24 Nov

UK Societas Page summary: Information on the administration and management of a UK Societas. Change made: Updated in line with changes to company registers and the launch of mandatory identity verification. Time updated: 12:01am, 18 November 2025 Interministerial Group on UK-EU Relations Communiqué: 12 May 2025 Page summary: The Interministerial Group on UK-EU Relations met on 12 May 2025. The…
Ben Kemp
December 5, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Environment, Food & Rural Affairs – WC 24 Nov

New law bans plastic wet wipes to protect rivers and seas Page summary: New law will ban the supply and sale of wet wipes containing plastic in England Change made: First published. Time updated: 11:10am, 18 November 2025 APHA Weybridge: general testing form (LSW008) Page summary: Submit samples to the Animal and Plant Health Agency (APHA) for commercial testing by…
Ben Kemp
December 5, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade – WC 24 Nov

Pan-Euro Mediterranean Convention on Rules of Origin (PEM) Page summary: The Department for Business and Trade (DBT) is seeking views on the potential impacts of UK accession to the Regional Convention on Pan-Euro Mediterranean Convention on Rules of Origin (PEM). Change made: First published. Time updated: 12:00pm, 17 November 2025 UK considers joining agreement to boost trade opportunities for British…
Ben Kemp
December 5, 2025
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