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Regulatory Affairs Newsletter

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

Product Regulation and Metrology Act 2025

New Legislation - Product Regulation and Metrology Act 2025 An Act to make provision about the marketing or use of products in the United Kingdom; about units of measurement and the quantities in which goods are marketed in the United Kingdom; and for connected purposes. However IVDs and Animal By-products are exempt, but Veterinary use and Research Use Only products…
Ben Kemp
July 30, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Yellow Card centre launched in Northern Ireland to strengthen patient safety

Yellow Card centre launched in Northern Ireland to strengthen patient safety Page summary: A new regional centre to promote Yellow Card reporting has been launched in Belfast today. Change made: Updated to reflect that the Northern Ireland Adverse Incident Centre (NIAIC) incident and reporting function will be closing. From the 1st August 2025, healthcare professionals in Northern Ireland will report…
Ben Kemp
July 30, 2025
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. 1) Regulations 2025

Dear Members, the The Data (Use and Access) Act 2025 (Commencement No. 1) Regulations 2025 has been published which brings into force as at 20th August 2025, large sections of the Data (Use and Access) Act 2025 published 19th June 2025. The Act covers access to customer data and business data, as well as: to make provision for the regulation…
Ben Kemp
July 30, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Regulation (EU) 2017/746 – mdc medical device certification GmbH (NB 483)

Dear Members, EU NANDO Database updated for Regulation (EU) 2017/746 (EUROPA – European Commission – Growth – Regulatory policy - SMCS ), Regarding the entry for - mdc medical device certification GmbH (NB 483). Total count of available Notified Bodies remains at 18, so this looks to be a change in scope of designation. View article...
Ben Kemp
July 30, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Historic Milestones: UK and Singapore join HealthAI

Historic Milestones: UK and Singapore join HealthAI Both Governments Building Global Momentum for Responsible AI in Health We are witnessing the emergence of a new era in healthcare AI governance, one where national boundaries give way to shared responsibility and multilateral collaboration. The recent expansion of our HealthAI Global Regulatory Network (GRN) marks not just institutional growth, but a fundamental…
Ben Kemp
July 30, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Biocides: EU active substance non-approval decisions and expiry date

Biocidal products must be phased off the NI market. Following evaluation/withdrawal of support under the EU Biocidal Products Regulation (EU BPR), a decision has been taken not to approve the following active substance/product type combinations. This will affect NI: 1,2-benzisothiazol-3(2H) - one (BIT) (CAS 2634-33-5 EC 220-120-9) in product type 2 Pyrithione zinc (CAS 13463-41-7 EC 236-671-3) in product types…
Ben Kemp
July 30, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New! Ensure Excellence in Molecular Testing with CLSI MM14

As molecular methods become essential in clinical diagnostics, the need for high-quality proficiency testing has never been greater. The brand new CLSI MM14—Design of Molecular Proficiency Testing/External Quality Assessment gives you the comprehensive guidance you need to establish or evaluate PT/EQA programs with confidence.   This essential resource covers: Creating reliable, high-quality PT/EQA schemes for molecular methods Best practices for…
Ben Kemp
July 30, 2025
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