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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
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

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

DSIT Updates (WC 6 Jan)

UK Science and Innovation Network impact stories Page summary: These impact stories highlight the work of the UK Science and Innovation Network (SIN) around the world. Change made: Added SIN impact story covering support for semiconductors in Japan. Time updated: 9:44am, 16 December 2024 Public attitudes to data and AI: Tracker survey (Wave 4) Page summary: Report detailing the findings…
Ben Kemp
January 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit: Safety and security requirements on imports and exports

Safety and security requirements on imports and exports Page summary: Find out about safety and security requirements that apply to goods entering and exiting the UK. Change made: Information about qualifying and non-qualifying goods arriving in Great Britain (England, Scotland and Wales) has been updated. Time updated: 2:00pm, 16 December 2024
Ben Kemp
January 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 6 Jan)

The UK and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) Page summary: Business guidance, treaty information and other documents to help you understand the UK’s accession to the CPTPP. Change made: Amended page to reflect ratification of UK’s membership of CPTPP. Time updated: 12:00am, 24 December 2024   UK trade agreements in effect Page summary: Find out about trade agreements…
Ben Kemp
January 8, 2025