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Ben Kemp

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
HighlightsHighlights Archive

Media Monitoring: 28th August – 3rd September

Busiest July on record for general practice teams General practice teams have delivered a record 33.6 million appointments in July 2025, up 4.3% on the year before and up nearly a quarter on the same period pre-pandemic (24.3% increase since 2019).  The statistics show the NHS is on-track for its busiest summer ever in general practice, with record appointments also delivered in…
Ben Kemp
September 2, 2025
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Study discovers cheek swab test provides early diagnosis of serious heart condition in children

A new, simple cheek-swab test, funded by the British Heart Foundation and unveiled at the European Society of Cardiology Congress in Madrid on 1 September 2025, may detect arrhythmogenic cardiomyopathy (ACM) years before symptoms appear. ACM is a genetic disorder responsible for over 10 percent of sudden cardiac deaths in children, caused by abnormalities in the proteins connecting heart cells…
Ben Kemp
September 2, 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
Events DiaryMembership NewsMembership News Archive

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
Membership NewsMembership News Archive

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
Membership NewsMembership News Archive

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
HighlightsHighlights Archive

UKHSA wastewater monitoring programme launched to catch pandemic threats

A programme has been expanded to evaluate how wastewater monitoring could be used to detect a wider range of dangerous pathogens has been launched by the UK Health Security Agency (UKHSA). Over the coming months, UKHSA laboratories, using £1.3 million of investment from the UK Integrated Security Fund (ISF), will assess the use of cutting-edge technologies to improve the UK’s…
Ben Kemp
September 2, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

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
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