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Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

BSI Standards update

  BSI Standards - Update on Projects Jan/Feb 2026 Status Date Description Committee Published 31/12/2025 BS EN ISO 1135-4:2025 Transfusion equipment for medical use. Transfusion sets for single use, gravity feed CH/212 - IVDs Published 31/12/2025 BS EN ISO 1135-5:2025 Transfusion equipment for medical use. Transfusion sets for single use with pressure infusion apparatus CH/212 - IVDs Published 31/01/2026 BS…
Ben Kemp
February 6, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU report emphasizes need for high value cancer care for all

EU report emphasizes need for high value cancer care for all Ahead of World Cancer Day, a new report has been published to provide fresh insights on disparities, challenges and good practices when it comes to cancer care. The EU-funded “Delivering High Value Cancer Care” report was produced by the OECD for the European Cancer Inequalities Registry, as part of…
Ben Kemp
February 6, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Medical Devices: Register now for high-level conference on 16 March 2026

Medical Devices: Register now for high-level conference on 16 March 2026 On 16 March, the European Commission will host a high-level conference in Brussels entitled “Medical Devices: Innovation and patient safety”, as part of the Cypriot Presidency. Olivér Várhelyi, EU Commissioner for Health and Animal Welfare, will deliver a keynote address at the event. Participants will include representatives from EU…
Ben Kemp
February 6, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Health Security Committee: Timely sharing of information and coordination of response

The Commission has yesterday adopted an implementing regulation, which lays down the necessary procedures for the Health Security Committee (HSC) to exchange information, consult and coordinate responses to cross-border health threats. Member States are required to inform, consult and coordinate on the adoption or termination of any public health measures linked to a serious cross-border threats within set timelines. The…
Ben Kemp
February 6, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027

Dear members, TGA has released their enforcement priorities for 2026-2027, with Direct to consumer IVDs being No. 1 on the list and Software as a Medical Device being No. 7 of the twelve key areas that they intend to focus on. The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027 The TGA Compliance Principles 2026…
Ben Kemp
February 6, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CLSI – Guidance documents update

New and updated standards Shop | Clinical & Laboratory Standards Institute Includes M100 Antimicrobial Susceptibility Testing 2026 EP05 Plus – Evaluation of Precision of Quantitative Measurement Procedures 4th Ed Dec 2025 MM19 – Establishing Molecular Testing in Medical Laboratory Environments Nov 2025   Documents for Public Review | CLSI EP17-Ed3 (Proposed Draft) - Evaluation of Detection Capability for Medical Laboratory…
Ben Kemp
February 6, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027

The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027 The Therapeutic Goods Administration (TGA) has released its compliance principles for the next 2 years, setting out a refreshed approach to compliance and enforcement to protect public health. The TGA Compliance Principles 2026 and 2027 outlines our strategic approach to monitoring and enforcing regulatory compliance for…
Ben Kemp
January 23, 2026
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