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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
Membership NewsMembership News Archive

ReMed Industrial Open Day – 11th November

Members are invited to an industrial open day organised by the ReMed project team (www.remed.uk) for the MedTech industry at Loughborough University on Tuesday 11 November. The event will include demonstrations of steps forward made in medical device recycling processes as part of the circular economy of medical devices, and will also focus on a proposed public-private initiative to establish…
Ben Kemp
October 7, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA guidance released: Clinical trials that include an in vitro diagnostic device

The MHRA has published guidance on clinical trials which include an in vitro diagnostic device. The guidance is split into three parts: definitions, using IVDs in a clinical trial, and applying for approval of a clinical trial that includes an IVD device. You can read the guidance here.
Ben Kemp
October 7, 2025
Membership NewsMembership News Archive

Helen speaks at the Health Innovation North Conference

Last week, BIVDA Chief Executive Helen Dent took part in panel on Accelerating Transformation: Developing Effective NHS/Industry Partnerships at the Health Innovation North Conference. The panel followed a session with NHS CEO Sir Jim Mackey. Helen spoke alongside the likes of new OLS Executive Chair Steve Bates and North East and North Cumbria NHS ICB CEO Samantha Allen. Helen declared…
Ben Kemp
October 7, 2025
Membership NewsMembership News Archive

NHS in the Community: Point of Care Testing Survey

NHS England North West Point of Care Testing strategy group, being run by Health Innovation North West Coast and the University of Lancashire, have released a short survey on the expansion of point of care testing. Specifically, they are looking to understand how patients would feel about the potential expansion of point of care testing to support health self-management and…
Ben Kemp
October 7, 2025
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