Identifying sepsis cases in administrative data: a validation study Page summary: UKHSA is working with the NHS to improve identification of sepsis in England. This study will help identify how many adults get sepsis in England and who is most affected. Change made: Updated vaccination study poster. Time updated: 5:15pm, 5 February 2026
Ben KempFebruary 6, 2026
Dear Members the following FDA Final Guidance updates have been issued Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions | FDA Computer Software Assurance for Production and Quality Management System Software | FDA Clinical Decision Support Software | FDA
Ben KempFebruary 6, 2026
Dear Members, please see the link to the notification that two substances have been added to the EU REACH Annex XIV candidate list of substances of very high concern. These being n-hexane and 4,4'-diphenol and its salts. 4,4'-diphenol is better known as Bisphenol AF and is a widely used plasticizer, and has been used as a substitute for Bisphenol A…
Ben KempFebruary 6, 2026
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 KempFebruary 6, 2026
Dear members, the next commencement date of the The Data (Use and Access) Act 2025 are due and cover a number of uses of data that will impact the sector including consent to processing for purposes of scientific research. The Data (Use and Access) Act 2025 (Commencement No. 6 and Transitional and Saving Provisions) Regulations 2026 These are…
Ben KempFebruary 6, 2026
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 KempFebruary 6, 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 KempFebruary 6, 2026
UK’s FCA Proposes IFRS-Aligned Sustainability Reporting Requirements for Companies Beginning 2027 UK FCA is proposing IFRS aligned Sustainability Reporting requirements for listed companies. The FCA’s consultation on the proposal is open until March 20, 2026, with the regulator aiming to publish a Policy Statement in autumn 2026, and to have the rules in force from the beginning of January 2027.…
Ben KempFebruary 6, 2026