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BIVDA meet Shadow Health Minister Lord Kamall

Last week, BIVDA's Helen Dent and Ben Kemp met with Shadow Health Minister Lord Kamall in the House of Lords. The peer was pleased to hear about BIVDA's ongoing advocacy efforts and key strategic objectives, as well as the challenges facing UK IVD companies. Lord Kamall, who was previously Life Sciences Minister under Boris Johnson, possesses a significant interest in…
Ben Kemp
October 21, 2025
Membership NewsMembership News Archive

Resolving menopause: better diagnostics are needed to navigate a challenging time in women’s lives

To mark World Menopause Day on 18th October, BIVDA member TTP plc published a blog aiming to demystify menopause and highlight the need for better diagnostic tools to improve women’s health outcomes. TTP notes that menopause is still too often diagnosed by exclusion rather than precision, leading to delays in care, patient frustration, and inefficient treatment pathways. The company argues…
Ben Kemp
October 21, 2025
Membership NewsMembership News Archive

DHSC launch survey on local formularies for medical devices

The Department of Health and Social Care (DHSC) has launched a national survey to inform new guidance for local NHS formularies listing medical devices prescribed for home or community use. The move follows long-standing concerns about regional variation in how NHS organisations manage these formularies, which can affect patient access to suitable devices. While NICE offers general advice on formulary…
Ben Kemp
October 21, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Diagnostic tools selected for phase 2 of the MHRA’s AI Airlock Programme

Seven emerging AI healthcare technologies have been selected to move into the next phase of the MHRA’s AI Airlock programme, with pleasing number of diagnostic tools chosen. The cohort includes tools aimed at dramatically reducing waiting times for tests, such as shrinking a bowel cancer screening process from weeks to minutes, and detecting conditions such as skin cancer, genetic eye…
Ben Kemp
October 21, 2025
Membership NewsMembership News Archive

Ben attends launch of the National Laboratories at LGC’s new purpose-designed facility in Guildford

Ben Kemp, BIVDA's Policy and Public Affairs Executive, was pleased to attend the Official Launch of the National Laboratories at LGC in Guildford on 17 October 2025. The National Laboratories at LGC are composed of three critical national functions; The National Measurement Laboratory (NML), the Government Chemist and the Medicines and Healthcare products Regulatory Agency’s (MHRA’s) chemical laboratories. These laboratories…
Ben Kemp
October 21, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA issues updated guidance to reflect the implementation of the revised fee structure

The MHRA have issued the revised DORS Fees Guidance to reflect the implementation of the revised fee structure being implemented from 1st April 2026. We have extracted the key sections from the updated MHRA product registration webpage for members below. Fees from 1 April 2026 A new fee is planned to come into effect on 1 April 2026 and will…
Ben Kemp
October 15, 2025
Membership NewsMembership News Archive

BIVDA 2026 Regulatory Affairs Seminar agenda released

The agenda for BIVDA's 2026 Regulatory Affairs Seminar has been released. In addition to the closing keynote from MHRA Chief Executive Lawrence Tallon, other sessions will include major updates on international global harmonisation, the future of regulatory affairs, AI digital trust, UK MDR Pre-Market Requirements, and more. Each session will be accompanied by a workshop to ensure attendees are able…
Ben Kemp
October 15, 2025
Membership NewsMembership News Archive

Vacancies available at Mast Group

Mast Group have a number of vacancies available and may be of interest to individuals looking to move within the IVD industry. The jobs are listed below: 1 Molecular Product Specialist - no region specified 2 Field Service Engineers due to extension of business - South Midlands for both positions 1 Territory Area Manager - London and South East 1…
Ben Kemp
October 14, 2025
Membership NewsMembership News Archive

Discover the future of HealthTech in West Yorkshire – 6th November

Members may be interested in attending this brand-new conference from Health Innovation Yorkshire & Humber and the West Yorkshire ICB’s HIVE Network. The conference is free to attend and open to local, national, and international HealthTech innovators at every stage of their journey, as well as research and innovation leaders from the West Yorkshire HIVE Network and the West Yorkshire…
Ben Kemp
October 14, 2025
Membership NewsMembership News Archive

DHSC Credentialing Update

Jim Morris, Head of Strategic Policy Initiatives at DHSC, has shared a timely update on the evolving hospital access credentialing landscape. Despite recent ministerial changes, the department remains committed to supporting industry-led self-regulation, echoing the direction set by Baroness Merron. DHSC is now actively engaging NHS England to define a clear 'demand statement' — a formal articulation of what the…
Ben Kemp
October 14, 2025
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