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Regulatory Affairs Newsletter Archive

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IEC 61326-2-6 Ed 4.0 2025-06 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

Dear members, The FDA yesterday announced its complete recognition of the International Electrotechnical Commission’s standard IEC 61326-2-6 Edition 4.0 2025-06. The standard applies to basic safety and essential performance of in vitro diagnostic medical electrical equipment when exposed to electromagnetic disturbances.   Date of Entry Specialty Task Group Area Recognition Number Extent of Recognition Standards Developing Organization Standard Designation Number…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Energy Security and Net Zero (WC 28 July)

UK Emissions Trading Scheme scope expansion: waste Page summary: The UK ETS Authority is seeking views on the implementation of the expansion of the UK Emissions Trading Scheme to energy from waste and waste incineration. Change made: Interim Authority response published. Time updated: 6:16pm, 21 July 2025 Integrating greenhouse gas removals in the UK Emissions Trading Scheme Page summary: The…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 28 July)

Proposed Statement of Strategic Priorities for telecommunications, the management of radio spectrum, and postal services Page summary: We are seeking views on the proposed Statement of Strategic Priorities for telecommunications, the management of radio spectrum, and postal services. Change made: First published. Time updated: 3:30pm, 21 July 2025 OpenAI to expand UK office and work with government departments to turbocharge…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Update (WC 28 July)

Boost in support for patients with chronic fatigue syndrome or ME Page summary: Better care for patients living with Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome, with plans to invest in research and offer closer to home. Change made: First published. Time updated: 12:01am, 22 July 2025 ME/CFS: the final delivery plan Page summary: The final delivery plan on myalgic encephalomyelitis/chronic fatigue…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Update (WC 28 July)

Designated standards: radio equipment Page summary: Notices of publication and a consolidated list for designated standards for radio equipment. Change made: Correction made to notice of publication 0119/25. Time updated: 9:58am, 21 July 2025 Refining the law to better protect consumers Page summary: The Product Regulation and Metrology Act 2025 enables the Government to amend regulations to reflect how products…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Notices under The Customs Transit Procedures (EU Exit) Regulations 2018 

Notices under The Customs Transit Procedures (EU Exit) Regulations 2018  Page summary: Notices under The Customs (Transitional Arrangements) (EU Exit) Regulations 2020 which have force of law under Customs Regulations. Change made: The listed locations under paragraph 2(A1) and 27(A1) of Schedule 1 of The Customs Transit Procedures (EU Exit) Regulations 2018 have been updated. Time updated: 1:43pm, 22 July…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business, Energy & Industrial Strategy Update (WC 28 July)

Designated standards: radio equipment Page summary: Notices of publication and a consolidated list for designated standards for radio equipment. Change made: Correction made to notice of publication 0119/25. Time updated: 9:58am, 21 July 2025 Labour market enforcement Page summary: Strategies and annual reports from the Director of Labour Market Enforcement. Change made: ‘Labour Market Enforcement Strategy 2025 to 2026’ added…
Ben Kemp
August 4, 2025
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ISO 15223-1 and the Authorized Representative Symbol

A significant change with broad implications ISO 15223-1 is a crucial standard for medical device manufacturers, providing symbols to convey information about devices without relying on text. This minimizes translation needs, frees up label space, and meets various regulatory requirements. On March 5, 2025, ISO 15223-1:2021/Amd 1:2025 introduced a significant change to the Authorized Representative symbol, altering the part of…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

HSA Software Guidance

HSA Singapore  GL-07 Guidance on Risk classification of SaMD and Qualification of Clinical Decision Support Software Rev 2. 2025/07 attached: https://www.linkedin.com/posts/stefano-bolletta-1bbb4437_hsa-activity-7353695372197642240-TY4R?utm_source=share&utm_medium=member_ios&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM
Ben Kemp
August 4, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

TuV SuD Guide on the interaction between the EU AI Act and the Medical Device legislation

TuV SuD guidance on the interaction between the EU AI Act and the medical devices legislation: https://www.linkedin.com/posts/ugcPost-7354976722951249920-TYVF?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM
Ben Kemp
August 4, 2025
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