Health Canada has updated its Guidance on applications for medical device licences, which becomes effective 02 Feb 2026.
Ben KempDecember 10, 2025
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 KempDecember 10, 2025
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 KempDecember 9, 2025
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 KempDecember 9, 2025
Dear members, please see below guidance from TGA on understanding their selection criteria for medical device application audits: https://www.tga.gov.au/resources/guidance/understanding-selection-criteria-medical-device-applicati…
Ben KempDecember 5, 2025
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 KempDecember 5, 2025
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 KempDecember 5, 2025
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 KempDecember 5, 2025
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 KempDecember 5, 2025