Skip to main content
search
Category

Regulatory Affairs Newsletter Archive

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

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
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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

Border Trade Newsletter – getting it right at the border 24 07 25

IDM Change Monday 28th July - Impact on Logging on to Defra Services An Identity Management (IDM) change is scheduled for Monday 28th July, between 19:00 and 21:00 (BST). IDM is the system used to authenticate users when logging on to various Defra services., this includes access to IPAFFS and the ALVS Help Desk Tool. During the change window, there…
Ben Kemp
July 30, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Invitation to Participate in EU4MEDTECH Questionnaire on Innovative and High-Risk MDs and IVDs

On behalf of the EU4MEDTECH project, you are kindly invited to participate in a short questionnaire designed to better understand the current practices, challenges, and digital needs of various stakeholder groups involved in the evaluation of innovative and high-risk medical devices (MDs) and in vitro diagnostic devices (IVDs). This initiative which is part of the EU4MEDTECH project, which aims to…
Ben Kemp
July 30, 2025
Close Menu