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APHA – Border Trade Newsletter – getting it right at the border 28 08 25

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 Kemp
September 8, 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
Near Patient Testing Working PartyRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UK MHRA CDx guidance for clinical trials updated 22AUG2025

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 Kemp
August 28, 2025
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A Deep Dive into Regulatory Intelligence in Europe

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 Kemp
August 28, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

TGA – Use of market authorisation evidence from comparable overseas regulatory and assessment bodies for medical devices (including IVDs)

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 Kemp
August 28, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CBAM: Final MedTech Europe response to EC public consultation

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 Kemp
August 28, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

(EU) 2024/1860 – IVDR 26 September 2025 deadline approaching

Critical Communication (EU) 2024/1860 – IVDR 26 September 2025 deadline approaching & impact on legacy devices not transitioning to the IVDR IVDD certified devices and Class D self-declared devices manufacturers to sign the written agreement with a Notified Body On 9 July 2024, the Regulation (EU) 2024/1860 amending the MDR and IVDR was published in the Official Journal of the…
Ben Kemp
August 28, 2025
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