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Regulatory Affairs Newsletter

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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
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Update (WC 28 July)

Air emissions risk assessment for your environmental permit Page summary: How to complete an air emissions risk assessment, including how to calculate the impact of your emissions and the standards you must meet. Change made: Updated the ‘Environmental Assessment Levels’ table to correct the following figures in the ‘Concentration in micrograms per cubic metre’ column: DEA, DEELA/DEEA, DiEA, MOR, NMOR,…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update (WC 28 July)

Medicines and Medical Devices Act 2021 – Stakeholder survey Page summary: We invite feedback on the operation and impact of the human medicines and medical devices legislation as part of a statutory review required under the Medicines and Medical Devices Act 2021. Change made: First published. Time updated: 9:10am, 21 July 2025 MHRA Performance Data Page summary: Performance data for…
Ben Kemp
August 4, 2025
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For information: EC consultation on delegated regulation on the export and import of hazardous chemicals

Dear members, Please see update below regarding update to the EU PIC (Prior Informed Consent) regulation, which has been update to reflect the inclusion of Dechlorane Plus and UV328 in the Stockholm convention on Persistent Organic Pollutants. The inclusion impacts notification requirements for imports and exports from the EU containing these substances. As the UK is also a signatory to…
Ben Kemp
August 4, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For information: UV-328 EU OJ Publication 15/7/2025

Dear Members, Update below from MedTech Europe  that the inclusion of UV328 in EU POPs regulation has been published in the OJEC. Note that EU POP regulation applies also in Northern Ireland. I anticipate a further update from HSE as to the inclusion of UV328 under UK POPs regulation. Dear members, I hope you are all well. We are writing…
Ben Kemp
August 4, 2025
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New Publication – Orphan IVDs – TEAM-NB

Dear Members, please see below update from MedTech Europe. This publication from Team NB outlines it’s position on Orphan IVDs under IVDR, which would also apply to Northern Ireland. It describes the suggested approach that the notified bodies would take when reviewing IVD that qualify as ‘orphan’ IVDs. There is a further meeting planned with the EC regarding the issue…
Ben Kemp
August 4, 2025
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