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Regulatory Affairs Newsletter Archive

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Public advised to stop using some non-sterile alcohol-free wipes

Public advised to stop using some non-sterile alcohol-free wipes Page summary: UKHSA and MHRA are urging the public not to use 4 specified non-sterile alcohol-free wipe products due to the risk of infection associated with their use. Change made: Updated with latest information. Time updated: 2:14pm, 5 February 2026
Ben Kemp
February 6, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Identifying sepsis cases in administrative data: a validation study

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 Kemp
February 6, 2026
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FDA Guidance Updates

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 Kemp
February 6, 2026
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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
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Data (Use and Access) Act 2025 (Commencement No. 6 and Transitional and Saving Provisions) Regulations 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 Kemp
February 6, 2026
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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
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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
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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
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Newsletter – January 2026

Preparing for the implementation and management of the new device registration fee We’ve published additional implementation and management guidance to help manufacturers, UK Responsible Persons and Authorised Representatives prepare for the new medical device registration fee, which comes into effect on 1 April 2026. The guidance explains how the fee will work and what organisations need to do to manage…
Ben Kemp
February 6, 2026
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