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
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
Dear members, following our feedback to the MHRA, on August 22nd the Clinical Trials Guidance page on gov.uk 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. Thanks to Alison Gillies, Leica Biosystems who spotted and reported the update, which I don’t…
Ben KempAugust 28, 2025
Advance with Insight. Lead with Intelligence. In an era of accelerated innovation and ever-changing global requirements, regulatory intelligence requires more than just knowledge — it demands foresight. The 2025 Regulatory Intelligence Conference Europe, an immersive two-day conference hosted by TOPRA and RAPS, is designed to equip you with the strategic insights and tools to stay ahead. Here’s a sneak peek…
Ben KempAugust 28, 2025
We are resharing this update from earlier in the year: TGA - Use of market authorisation evidence from comparable overseas regulatory and assessment bodies for medical devices (including IVDs) Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA) Mentions CE to the directives and the regulation for…
Ben KempAugust 28, 2025
MedTech Europe have responded to the EU Carbon Border Adjustment Mechanism consultation. The current position is that this would impact not only importers of in scope materials, but also some products made of these energy intensive materials which includes Aluminium, Iron, Steel, Glass and Ceramics, if they are not produced as Net Zero products. At this current time, the EU…
Ben KempAugust 28, 2025