Self-sampling at the point-of-care – enhancing access, improving care As the UK regulator for medical devices, the MHRA ensures that self-sampling devices are safe, effective, and properly registered before they can be used. This article, which the MHRA have co-authored with the Royal College of Pathologists, sets out clear guidance on regulation, including device marking (UKCA/CE), transport requirements, and the…
Ben KempSeptember 8, 2025
Defra UK REACH Consultation: extension of transitional registration deadlines The Defra UK REACH Consultation on the extension of transitional registration deadlines is still open. Defra want to hear your views on government proposals to extend: the UK REACH deadlines for businesses to submit dossiers for transitional registrations the dates for HSE (the UK REACH agency) to carry out compliance checks…
Ben KempSeptember 8, 2025
Getting it right at the border This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: IPAFFS Scheduled Update - Monday, 1 September ABP importer declarations Extra border checks cancelled ahead…
Ben KempSeptember 8, 2025
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 KempSeptember 3, 2025
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 KempSeptember 2, 2025
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 KempSeptember 2, 2025
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 KempSeptember 2, 2025
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 KempSeptember 2, 2025
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 KempSeptember 2, 2025