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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
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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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BIVDA to host Envetec & My Green Lab webinar: Sustainability in IVD – Turning Waste into Resource and Assessing Product Impact

BIVDA are hosting a webinar led by Envetec and My Green Lab on 14th October 2025 at 15:00 to 16:00, which will explore practical solutions for a sustainable diagnostics product lifecycle. Envetec will be speaking about enabling new circular economy opportunities for IVD waste. Through their GENERATIONS technology, Envetec are lowering carbon emissions across the biohazardous waste disposal chain and…
Ben Kemp
September 2, 2025
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NIHR HRC online course: Evidence Generation for Diagnostics Development – 30th Sept & 1st Oct

Registration is now open for the NIHR HealthTech Research Centre course on Evidence Generation for Diagnostics Development. New diagnostics provide great advantages to patient care. However, diagnostics developers need to provide a portfolio of evidence that demonstrates these benefits before their technologies can reach the UK market and benefit patients, the public and the health and care system. On 30…
Ben Kemp
September 2, 2025
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Industrial partner sought for collaboration on a funding proposal to Medical Research Scotland (MRS)

Professor Maiwenn Kersaudy-Kerhoas of Heriot-Watt University is seeking an industrial partner to collaborate on a funding proposal to Medical Research Scotland (MRS). Professor Kersaudy-Kerhoas has developed a prototype of a completely manual cell-free DNA (cfDNA) extraction cassette, designed for use in combination with DNA-based lateral flow assays. She is seeking to partner with an organisation that has a need for…
Ben Kemp
September 2, 2025
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DHSC Call for Evidence on Pathology Managed Services – deadline extended to 19th September

The Department of Health and Social Care (DHSC) has extended the deadline for its Call for Evidence on Pathology Managed Service Contracts to 19th September 2025, allowing members more time to take advantage of this vital opportunity for our industry to shape the future of pathology procurement in the NHS. Managed service contracts are central to how pathology services operate. The decisions…
Ben Kemp
September 1, 2025