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BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New Chair of UKCA Subgroup announced

BIVDA is pleased to inform members that James Barker (Cytocell) has accepted the post of co-chair of the UKCA Subgroup. James will work alongside the existing chair, Emma Barringer. James is a regulatory professional with almost 20 years of experience in the IVD sector, currently serving as Regulatory Affairs Manager at Oxford Gene Technology (OGT) in Cambridge, UK. Over the…
Ben Kemp
June 17, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA announce new Post-Market Surveillance (PMS) regulations have taken effect

From the 16th June 2025, new legal requirements for monitoring the safety of medical devices take effect, as part of the MHRA's broader transformation of the UK’s medical device regulatory framework. The new Post-Market Surveillance (PMS) regulation is the first major overhaul of medical device regulation across Great Britain. The reform applies to all UKCA- and CE-marked devices placed on…
Ben Kemp
June 17, 2025
Membership NewsMembership News Archive

Make sure to register for the Near-Patient Testing Working Party — 3rd July

Join BIVDA's next Near Patient Testing Working Party meeting on Thursday 3rd July, 2pm - 4.30pm at our offices. We will be moving to a new, exciting format for our next NPT meeting to encourage discussions and conversations. Near Patient Testing - Actionable Steps towards the challenges of NPT Together we want to create actionable steps towards the challenges that we face…
Ben Kemp
June 17, 2025
Membership NewsMembership News Archive

BIVDA welcomes Viscera Technologies as new BIVDA members

BIVDA are pleased to welcome Viscera Technologies as new BIVDA members. Viscera Technologies brings laboratory-precision testing directly to patients through smartphone-powered lateral flow analysis. Their platform delivers quantitative results in minutes, not days, making professional-grade diagnostics accessible anywhere. They combine patented lateral flow technology with intelligent self-correcting algorithms—delivering laboratory precision anywhere, with any smartphone, enabling healthcare providers to make confident…
Ben Kemp
June 17, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Pathology Managed Services Policy Guidance Development – DHSC Call for Evidence launched

Many of you will be aware of the work undertaken by BIVDA and members over the last six months to make the case to DHSC for improving the approach to the procurement of Pathology Managed Services in the NHS. This has now culminated in a "call for evidence" launched last week by DHSC. This call for evidence will be the…
Ben Kemp
June 16, 2025
Membership NewsMembership News Archive

BIVDA’s message from NHS Confed Conference: “United we deliver, divided we fail”

BIVDA's own Beth Loudon attended the NHS Confed conference in Manchester last week and provided a summary of some of the key messages and themes. The event was well-attended with over 9,000 delegates registered, complete with multiple stages prepared for the conference's prestigious line-up of speakers. The main themes over the course of the conference were innovation, addressing health inequalities…
Ben Kemp
June 16, 2025
Membership NewsMembership News Archive

BIVDA member Viscera runner-up for Best Digital Health prize at Prix Galien UK Awards

At last week's Prix Galien awards, new BIVDA member Viscera Technologies' flagship innovation, Quantico, was declared runner-up in the Best Digital Health category. Quantico is the first lateral flow testing platform built around the smartphone. Capable of quantifying biomarkers using only a test strip, a sample and Lab-Flow technology — complemented by a proprietary app that automatically corrects for ambient…
Ben Kemp
June 11, 2025
Events DiaryMembership NewsMembership News Archive

Upcoming Webinar: IVDs in the field of Clinical Genomic Testing – Global overview

The webinar is jointly organised by BIVDA, the ACGS QSC, RCPath Genomics SAC, and AMP. Join for an exclusive webinar on 20th June, chaired by BIVDA President Angela Douglas and featuring expert insights on the latest IVD related updates from the UK, EU, and USA. With regulatory landscapes evolving across the UK, EU, and USA, staying informed is essential for…
Ben Kemp
June 10, 2025
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