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BIVDA Member Survey incoming

The BIVDA Member Survey is set to be released shortly and we ask members to respond when it lands in their inbox. The survey should take just 5 minutes to complete and will allow members to provide BIVDA with feedback on how we operate, what improvements we could make, and which member priorities we should focus on. Member feedback is…
Ben Kemp
September 16, 2025
HighlightsHighlights Archive

Blood test trial for over 1,000 dementia sufferers in potential Alzheimer’s breakthrough

Over 1,000 suspected dementia sufferers are to be offered a potentially revolutionary Alzheimer's blood test. UCL scientists leading the trial believe the test will improve the accuracy of diagnosis from 70% to more than 90%. The test measures a biomarker called p-tau217 — associated with the build-up of harmful proteins in the brain — and will be used alongside traditional…
Ben Kemp
September 16, 2025
Membership NewsMembership News Archive

BIVDA – BSI Webinar: EU RED cybersecurity mandatory requirements for IVDs

Online - 10am - 11am, Wednesday 15th October  BIVDA welcome BSI to deliver a webinar exploring the new EU RED cybersecurity mandatory requirements came into force on 1st August 2025 and how they are interfacing with IVD cybersecurity obligations. BSI will start by clarifying the RED updated scope, devices under scope and why IVDs are formally exempt of these new cybersecurity requirements, but…
Ben Kemp
September 16, 2025
Membership NewsMembership News Archive

BIVDA Spotlight: Clinical Immunology Services

Who we are: The Birmingham University Clinical Immunology Services is a unique intersection of skills with clinicians, biomedical scientists, clinical scientists and researchers coming together to leverage our positioning in the intersection between academic research studies, assay development and commercialisation with private industry, and the NHS for whom we provide a routine clinical service. We have just moved into new…
Ben Kemp
September 16, 2025
Membership NewsMembership News Archive

Mind the Gap

Advancing the 100 Days Mission for Diagnostics: 2025 Global Gap Assessment is a report developed by the International Pandemic Preparedness Secretariat (IPPS) in collaboration with the Brown University Pandemic Center and FIND, the global alliance for diagnostics. It identifies persistent barriers in diagnostic preparedness that continue to undermine efforts to prevent future pandemics and provides the first in-depth assessment focused specifically…
Ben Kemp
September 16, 2025
Membership NewsMembership News Archive

Simple lung test TPP – survey input required

Have your say on the new innovations needed in GP clinics to deliver better solutions for diagnosing chronic lung disease. LifeArc, Asthma + Lung UK and NIHR HealthTech Research Centre in Diagnostic and Technology Evaluation are producing a target product profile (TPP) that will be a list of instructions to new test developers, ensuring the most needed tests reach the…
Ben Kemp
September 15, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Big Changes Coming: North American Packing Laws…

Thursday, September 18 10 AM ET  /  7 AM PT  /  4 PM CET Extended producer responsibility (EPR) laws are moving fast across the U.S. and Canada, and manufacturers are already on the hook for product end-of-life management. The cost of inaction? Fines, lawsuits, and potential loss of market access. Join our upcoming webinar to get clear on what these…
Ben Kemp
September 12, 2025