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Regulatory Affairs Newsletter

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Health Technology Assessment – Commission adopts rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices

Health Technology Assessment - Commission adopts rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices Today, the European Commission adopted an implementing regulation establishing the rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the…
Ben Kemp
October 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Radio Equipment (Amendment) (Northern Ireland) Regulations 2025

Dear members, please be advised of the plan to amend The Radio Equipment Regulations 2017 in the context of Northern Ireland. This legislation introduces the EU Radio Equipment Directive Cybersecurity Requirements to radio equipment placed on the Northern Ireland market. The Radio Equipment (Amendment) (Northern Ireland) Regulations 2025 The Windsor Framework requires that the European Union (“EU”) legislation listed in…
Ben Kemp
October 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Active EU substance dossier submission deadline and renewal submission deadlines

Upcoming EU active substance renewal submission deadlines Apply for active substance renewal by the relevant deadlines to keep products on the NI market. Under the EU Biocidal Products Regulation (EU BPR), active substance approvals will expire unless a renewal application is submitted to ECHA at least 550 days before their expiry date. The 550-day deadlines are coming up for the…
Ben Kemp
October 22, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EC survey on medical device supply chain and shortages – invitation to participate (deadline: 03/11/2025)

Dear members, the European Commission (DG SANTE/HaDEA) has organised a survey to gather information to inform future policy regarding medical device supply chains, and management of shortages, and to provide resilience in the supply chains of medical devices. The general objective of the study, which started in June 2025 and will last six months, is to provide a comprehensive understanding…
Ben Kemp
October 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Are you ready for easier patent management?

Are you ready for easier patent management? Patent management is about to become much easier with our One IPO Patent Service launching in spring 2026. The most popular features in our pilot have been the patent management tools - and it's easy to see why. Currently, making changes to your patents involves completing paper forms, emailing them to us, and…
Ben Kemp
October 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Moving to a single list for UK sanctions designations

The UK Government is consolidating the sanctions lists impacting exports. Generally IVD products are not directly impacted, but any items considered dual use (having encryption software etc.) can be impacted. Sanctions on Russia and Belarus have had an indirect impact in terms of impacting banking and legal services in support of IVD sales to Russia, and for companies getting payment…
Ben Kemp
October 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Environment, Food & Rural Affairs Updates: WC 13th October

Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated the lists of businesses approved to export to the EU. Time updated: 2:28pm, 7 October 2025 Lumpy skin disease in…
Ben Kemp
October 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Updates: WC 13th October

New funds for local leaders to unlock jobs and boost innovation across the country Page summary: Up to £20 million each available for local areas across the country to grow innovation. Change made: First published. Time updated: 12:01am, 6 October 2025 IT Reuse for Good charter Page summary: Organisations and public bodies, express you interest and sign this charter to…
Ben Kemp
October 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates: WC 13th October

Industrial Strategy quarterly update: July to September 2025 Page summary: An update on delivery of commitments in the Industrial Strategy. Change made: First published. Time updated: 10:57am, 7 October 2025 UK’s Industrial Strategy hits the ground running, securing £250bn in investment and supporting 45,000 jobs Page summary: The Government has announced that it has secured over £250 billion of investment…
Ben Kemp
October 21, 2025
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