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Office for Product Safety and Standards (WC 12 Jan)

Regulators: professional guidance and tools Page summary: Resources for regulators. Change made: Link added to guidance on EU Regulation 2023/988 on General Product Safety. Time updated: 9:36am, 7 January 2025 Designated standards: PPE Page summary: Notices of publication and a consolidated list for designated standards for personal protective equipment (PPE). Change made: Notice of publication amended and consolidated list updated.…
Ben Kemp
January 17, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 12 Jan)

New regional skills projects to bolster UK cyber defences and deliver on Plan for Change Page summary: More than 30 projects across England and Northern Ireland will deliver targeted support to boost the UK’s cyber resilience. Change made: First published. Time updated: 12:01am, 8 January 2025 Evaluation of the Northern Ireland Cyber AI Hub programme Page summary: A report setting…
Ben Kemp
January 17, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 12 Jan)

DBT and CMA memorandum of understanding: international cooperation Page summary: Memorandum of understanding between the Department for Business and Trade (DBT) and the Competition and Markets Authority (CMA) regarding international cooperation on competition and consumer law enforcement. Change made: First published. Time updated: 12:00pm, 6 January 2025 Creating a smart data economy Page summary: Through championing smart data, we are…
Ben Kemp
January 17, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Defra – BTOM update – getting it right at the border 09 01 25

Check the CHED reference in customs declarations Please ask your customs agent to carefully check the CHED import notification reference that they are adding into a customs declaration for your consignments. CHEDs submitted on IPAFFS from 1 January 2025 will have a ‘2025’ prefix.  Customs declaration with incorrect ‘2024’ CHED references may cause delays in processing or incorrect holds to appear…
Ben Kemp
January 17, 2025
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MHRA Release Post-Market Surveillance Guidance

The MHRA have released their guidance on new GB PMS requirements, introduced with the new PMS Statutory Instrument.  The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 amends the UK Medical Device Regulations 2002. The MHRA recommends members to start using the guidance immediately, to ensure you are prepared for when the new PMS requirements become mandatory from…
Ben Kemp
January 15, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Border Target Operating Model – getting it right at the border 19/12/24

Border Services update from HMRC – Goods Vehicle Movement Service (GMVS)   Following weather damage caused by Storm Darragh, Holyhead Port has needed to temporarily close for urgent repair works and is not expected to open until at least 15 January 2025.   HMRC continues to work with Holyhead Port, the affected maritime carriers and with Border Force to monitor…
Ben Kemp
January 9, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

As promised by the MHRA, the Post Market Survailence Statutory Instrument 2024 No. 1368  modifying the UK MDR 2002 (as amended), has been published 16th December 2024, and there for applies for all IVD’s placed on the GB market from 16th June 2025. If you’ve not already started preparing your Quality Management systems for the update, now the time to…
Ben Kemp
January 8, 2025