Take action to keep your active substance in the EU Review Programme. The active substance/product type combinations listed have been successfully notified into the EU Review Programme following open invitations. The next step is for a full active substance dossier to be submitted to the European Chemicals Agency (ECHA) by the following deadline. This affects NI: 8 January 2027 Chlorine…
Ben KempJuly 30, 2025
Dear Members, the The Data (Use and Access) Act 2025 (Commencement No. 1) Regulations 2025 has been published which brings into force as at 20th August 2025, large sections of the Data (Use and Access) Act 2025 published 19th June 2025. The Act covers access to customer data and business data, as well as: to make provision for the regulation…
Ben KempJuly 30, 2025
Dear Members, EU NANDO Database updated for Regulation (EU) 2017/746 (EUROPA – European Commission – Growth – Regulatory policy - SMCS ), Regarding the entry for - mdc medical device certification GmbH (NB 483). Total count of available Notified Bodies remains at 18, so this looks to be a change in scope of designation. View article...
Ben KempJuly 30, 2025
Historic Milestones: UK and Singapore join HealthAI Both Governments Building Global Momentum for Responsible AI in Health We are witnessing the emergence of a new era in healthcare AI governance, one where national boundaries give way to shared responsibility and multilateral collaboration. The recent expansion of our HealthAI Global Regulatory Network (GRN) marks not just institutional growth, but a fundamental…
Ben KempJuly 30, 2025
Regulations: restriction of hazardous substances (RoHS) Page summary: Guidance for manufacturers, importers and distributors. Change made: Links added to revised GB and NI guides for businesses. Time updated: 11:34am, 22 July 2025
Ben KempJuly 30, 2025
Biocidal products must be phased off the NI market. Following evaluation/withdrawal of support under the EU Biocidal Products Regulation (EU BPR), a decision has been taken not to approve the following active substance/product type combinations. This will affect NI: 1,2-benzisothiazol-3(2H) - one (BIT) (CAS 2634-33-5 EC 220-120-9) in product type 2 Pyrithione zinc (CAS 13463-41-7 EC 236-671-3) in product types…
Ben KempJuly 30, 2025
As molecular methods become essential in clinical diagnostics, the need for high-quality proficiency testing has never been greater. The brand new CLSI MM14—Design of Molecular Proficiency Testing/External Quality Assessment gives you the comprehensive guidance you need to establish or evaluate PT/EQA programs with confidence. This essential resource covers: Creating reliable, high-quality PT/EQA schemes for molecular methods Best practices for…
Ben KempJuly 30, 2025
Your chance to shape the UK's connected future in new SEPs consultation The IPO has launched a consultation on Standard Essential Patents (SEPs) to boost UK innovation and help businesses navigate the complex world of connected technologies. The consultation, which runs until 7 October 2025, represents a critical step towards creating a more transparent and efficient SEPs ecosystem that works…
Ben KempJuly 30, 2025
Dear Members, please see this MedTech Europe update on the French Triman Logo implementation under the EU Packaging Labelling Directive. Dear members, Please be informed that following its letter of formal notice in February 2023 and its reasoned opinion in November 2024, the European Commission has now decided to refer France to the Court of Justice of the European Union for failing…
Ben KempJuly 30, 2025