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Regulatory Affairs Newsletter Archive

UK MHRA CDx guidance for clinical trials updated 22AUG2025 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
A Deep Dive into Regulatory Intelligence in Europe Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

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
TGA – Use of market authorisation evidence from comparable overseas regulatory and assessment bodies for medical devices (including IVDs) 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
CBAM: Final MedTech Europe response to EC public consultation 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
(EU) 2024/1860 – IVDR 26 September 2025 deadline approaching 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
For approval by 6 August: RoHS Renewals Batch 2 MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For approval by 6 August: RoHS Renewals Batch 2

Dear members, please see below update regarding submission for EU RoHS Annex III exemption packs 4(a)-I and 4(f)-IV regarding lamps, specifically mercury containing lamps used because they emit light in the UV wavelengths.  The joint submissions have been made under the Umbrella project and via Lighting Europe. These will also apply in Northern Ireland. Please note that members interested in…
Ben Kemp
August 28, 2025
BS EN IEC 82474-1:2025 Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

BS EN IEC 82474-1:2025

Dear members, please be advised that the following standard regarding full material declarations has been published. Derived from the existing IEC standard  BS EN IEC 62474:2019+A1:2021 | 31 Jan 2021 | BSI Knowledge for full material declarations for products of and for the electrotechnical industry. BS EN IEC 82474-1:2025 | 31 Jul 2025 | BSI Knowledge The standard provides a…
Ben Kemp
August 28, 2025
QServe Australia UDI Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

QServe Australia UDI

Qserve perspective on the new Australian TGA UDI requirements. Increasingly relevant as Australia is one of the countries MHRA have identified from international recognition under the proposals for the Pre-Market SI. *Please note, the above post on TGA UDI requirements shows the timelines table for medical devices rather than the IVD table as below.   TGA UDI Timelines for IVDs…
Ben Kemp
August 28, 2025