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Ben Kemp

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
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
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
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
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Updates (WC 25 Aug)

AI to cut paperwork to free up doctors’ time for patients Page summary: Patients and frontline staff could see huge benefits from new AI helping people out of hospital quicker and slashing bureaucracy. Change made: First published. Time updated: 10:30pm, 16 August 2025 AI Exemplars programme Page summary: AI Exemplars are transforming public services – improving healthcare, education, planning and…
Ben Kemp
August 28, 2025
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