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The Radio Equipment (Amendment) (Northern Ireland) Regulations 2025

Dear members, please be advised that the below update of Northern Ireland Legislation introduces the EU  2022/30 implementing legislation on Cybersecurity requirements to the Radio Equipment Directive. Medical Devices and IVDs are exempt, however off the shelf IT equipment with radio functions are in scope, this means that such equipment including that provided with IVDs, placed on the Northern Ireland…
Ben Kemp
December 10, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Biocidal Products (Data Protection Periods) (Amendment) Regulations 2025

Please note the below update to the UK Biocidal products regulation: The Biocidal Products (Data Protection Periods) (Amendment) Regulations 2025 These Regulations amend Article 95 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (EUR 2012/528) (“the GB Biocidal Products…
Ben Kemp
December 10, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Changes to Article 95 of GB Biocidal Products Regulation

Dear members, please be advised that if you are submitting data in support of a Biocides application that the data protection periods are being extended as per the below notification. Changes to Article 95 of GB Biocidal Products Regulation Regulations have been laid in Parliament to change the data protection end date in Article 95(5) to 31 December 2030. The…
Ben Kemp
December 10, 2025
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Windows 10 end of support: Potential impact on medical devices

Dear members, please see below TGA post regarding Windows 10 end of support: Potential impact on medical devices. It doesn’t take into account LTSC Enterprise licences (End of support 12 Jan 2027) or Enterprise IoT licences which have an end of support scheduled in 2032. Some medical devices could be affected by the end of support for the Microsoft Windows…
Ben Kemp
December 10, 2025
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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
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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
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