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Use of legislative powers related to recalls and other market actions

Dear Members, TGA Australia have issued an update on use of legislative powers related to recalls and other market actions Guidance to help sponsors understand the legislative powers the TGA can use relating to market actions. View article...
Ben Kemp
February 27, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MedTech Europe – Clinical evidence requirements ebook fourth edition published

Dear Members, if you’re not already aware, MedTech Europe published the 4th Edition of the Clinical Evidence Guidance available to download from: Clinical Evidence Requirements for CE certification - MedTech Europe.
Ben Kemp
February 27, 2026
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WHO Position Note on Accessories

Dear Members, WHO has issued a Position Note on Accessories Position Note on Accessories Published | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control) This provides guidance regarding accessories supplied with WHO Pre-Qualified Devices.
Ben Kemp
February 27, 2026
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NICE – Statement of intent – NICE’s approach ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds

Dear members, please see below update from NICE - Statement of intent - NICE's approach ongoing evaluations ahead of proposed changes to NICE's standard cost-effectiveness thresholds. Overview | Statement of intent on NICE’s approach to ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds | Guidance | NICE
Ben Kemp
February 27, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MTE- EU-US Tariffs – Situation Update

An update from MedTech Europe on the current US-EU tariffs situation. Last Friday, the Supreme Court in the US, has ruled (6:3) against president Trump’s imposition of tariffs pursuant to the International Emergency Economic Powers Act (IEEPA) 24-1287 Learning Resources, Inc. v. Trump (02/20/2026) The ruling has invalidated the legal basis for the US’ broad, sudden tariffs such as the…
Ben Kemp
February 27, 2026
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Consultation: TGA Annual Charge Exemption (ACE) Scheme Compliance Program Updates proposal 2026-27

Consultation: TGA Annual Charge Exemption (ACE) Scheme Compliance Program Updates proposal 2026-27 We have opened a consultation to provide industry and other interested stakeholders with an opportunity to comment on the our proposed updates to the ACE Scheme Compliance Program View article...
Ben Kemp
February 26, 2026