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Register now to attend POCT Innovators’ The Power to Disrupt Through Diagnostics in December

Sign-up to POCT Innovators' (Tony Cambridge) latest event 'The Power to Disrupt Through Diagnostics' at the National Army Museum, London on Monday 15th December 2025 here. 🎟️ Tickets: NHS/Public Sector/Academia: Free* Commercial: £149 early bird booking before 3rd October, rising to £249 plus VAT From 3rd October Agenda at a Glance The Ten-Year Health Plan: System Leadership and the Role of Diagnostics…
Ben Kemp
September 9, 2025
Membership NewsMembership News Archive

Help shape the future of NICE

The National Institute for Health and Care Excellence (NICE) is conducting an important research project that will help them to better understand the views and experiences of their audiences, informing the future development of NICE. The results of the following survey will be presented to NICE's Board, and those sharing their views will play an important part in shaping their…
Ben Kemp
September 9, 2025
Membership NewsMembership News Archive

Join the Standardisation of Genome Amplification Techniques and Serology (SoGATS) workshop on 24 – 26 September 2025

This is your last chance to register for the 2025 Standardisation of Genome Amplification Techniques and Serology (SoGATS) Workshop to be held on 24 - 26 September 2025, at the Medicines and Healthcare products Regulatory Agency (MHRA) Science Campus in Hertfordshire, UK. You can also join the workshop online. The workshop programme can be found here and includes talks from…
Ben Kemp
September 9, 2025
Membership NewsMembership News Archive

CACLP Webinars: Unlocking opportunities in China

CACLP, China’s leading laboratory medicine event, is planning a series of webinars on Unlocking Opportunities in China. Sign-up to learn: Latest statistics on the Chinese IVD / laboratory medicine market Where are the biggest opportunities for international companies? An overview of CACLP: What you need to know Feedback from a company who visited the show in 2025 Practical information for…
Ben Kemp
September 9, 2025
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Registration opened for BIVDA’s 2026 Regulatory Affairs Seminar

After last year’s record-breaking event, BIVDA is excited to hold the 2026 Regulatory Affairs Seminar, between 10–11 February in Birmingham. This year promises to be bigger than ever — unmissable for any regulatory affairs professional in diagnostics. Whether you’re driving innovation to market, steering post-market strategy, or hungry for expert insight into where UK regulations are heading, this seminar is…
Ben Kemp
September 9, 2025
Membership NewsMembership News Archive

Last chance – Webinar: Diagnostics as a cornerstone of the UK National Action Plan for AMR

The Royal College of Pathologists, in partnership with BIVDA member Biomerieux, are hosting a webinar on Thursday 11th September at 12:30 titled 'Diagnostics as a cornerstone of the UK National Action Plan for Antimicrobial Resistance (AMR). In this webinar, Amelia Worley, Policy Lead for AMR, Sepsis and IPC in the Department of Health and Social Care (DHSC), will give an overview…
Ben Kemp
September 9, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes updated Government Response to the Consultation on Statutory Fees for medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) published an update to the Government Response to the MHRA Consultation on Statutory Fees for medical devices yesterday. This follows a consultation in 2024 which proposed fee increases which would have made many in vitro diagnostic products unviable for the UK market. BIVDA were supported by members to respond to the consultation…
Ben Kemp
September 3, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA updated clinical trials guidance for companion diagnostics

Following BIVDA's feedback to the MHRA, on August 22nd the Government's Clinical Trials Guidance page was updated. The update includes specifics of trial submission when companion diagnostics are involved in GB. Separate IVDR related guidance applies to trials conducted in Northern Ireland. You can find the latest guidance here.
Ben Kemp
September 2, 2025
Membership NewsMembership News Archive

Helen to speak at WHF Life Sciences Conference chaired by Kit Malthouse MP

BIVDA Chief Executive Helen Dent will speak at the Westminster Health Forum online conference, "Next steps for the life sciences industry in the UK". Taking place on Wednesday, 15th October 2025 at 9am - 1pm, the event will be chaired by Chair of the Life Sciences APPG, Kit Malthouse MP, and feature speakers including National Director for Life Sciences at NHS…
Ben Kemp
September 2, 2025
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