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Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Updates (WC 25 Aug) 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 25 Aug)

AI to cut paperwork to free up doctors’ time for patients Page summary: Patients and frontline staff could see huge benefits from new AI helping people out of hospital quicker and slashing bureaucracy. Change made: First published. Time updated: 10:30pm, 16 August 2025 AI Exemplars programme Page summary: AI Exemplars are transforming public services – improving healthcare, education, planning and…
Ben Kemp
August 28, 2025
Department for Environment, Food & Rural Affairs Updates (WC 25 Aug) 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 25 Aug)

Extended producer responsibility for packaging: templates for sampling and inspection plans Page summary: If you are required to apply for registration as a reprocessor or exporter of packaging waste under extended producer responsibility (EPR) for packaging, and to apply for optional accreditation, you must submit a sampling and inspection plan using these templates. Change made: This adds the overseas reprocessing…
Ben Kemp
August 28, 2025
Department for Business and Trade Updates (WC 25 Aug) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates (WC 25 Aug)

Ceri Morgan Appointed Trade Commissioner for Europe Page summary: Ceri Morgan Appointed as His Majesty’s Trade Commissioner for Europe Change made: First published. Time updated: 12:01am, 18 August 2025 Northern Ireland science and tech industries boosted by over £30 million from UK Industrial Strategy Page summary: Major win for Northern Ireland’s high-tech sectors from the UK’s modern Industrial Strategy, supporting…
Ben Kemp
August 28, 2025
Animal and Plant Health Agency Updates (WC 25 Aug) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates (WC 25 Aug)

Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated the list of professionals who can certify export health certificates in England and Scotland. Time updated: 12:09pm, 20 August 2025 Animal…
Ben Kemp
August 28, 2025
Office for Product Safety and Standards Updates (WC 25 Aug) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Updates (WC 25 Aug)

Regulations: timber and FLEGT licences Page summary: Guidance for businesses trading in timber and timber-related products. Change made: Due dilligence guide updated. Time updated: 3:43pm, 20 August 2025
Ben Kemp
August 28, 2025
The Animal Products (Control of Personal Importation) (Scotland) Order 2025 Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Animal Products (Control of Personal Importation) (Scotland) Order 2025

Please note that Scotland has updated its controls of animal products for personal importation. Although this is aimed mainly at passengers bring goods back to Scotland, it also includes shipment to individuals not intended to be placed on the market, and Animal By-products and derived products are in scope. The Animal Products (Control of Personal Importation) (Scotland) Order 2025 This…
Ben Kemp
August 28, 2025
EN IEC 61326-2-6:2025 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical electrical equipment Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EN IEC 61326-2-6:2025 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical electrical equipment

Dear members, CENELEC have adopted EN IEC 61326-2-6:2025 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical electrical equipment (publication date=2025-08-22) as a European standard. This has not been harmonised to the IVDR at this time. View article... Adoption as a British Standard is currently proceeding British…
Ben Kemp
August 28, 2025
FDA New Classifications published FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA New Classifications published

Dear members, Neil Plumridge spotted the following Politico article regarding updates to FDA classifications: Devices, diagnostics and digital health CLASSIFICATION ORDER BONANZA: The FDA’s Center for Devices and Radiological Health today issued nine medical device classification orders, primarily (eight out of the nine) for diagnostic products. The issuance of these orders is the last step in formally codifying a new…
Ben Kemp
August 22, 2025
For input by 29/8: ECHA RAC Talc Opinion/Classification Carcinogenic 1B MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For input by 29/8: ECHA RAC Talc Opinion/Classification Carcinogenic 1B

Dear members, please see below call for feedback regarding the classification of ‘Talc’ as Class 1B Carcinogen. The focus is on Medial devices. I’m not aware of any IVD devices that utilise ‘Talc’, but if your impacted please contact me via regulatory@bivda.org.uk We are writing to inform you that recently, the European Chemical Agency’s (ECHA) Risk Assessment Committee (RAC) published…
Ben Kemp
August 22, 2025
APHA – Border Trade Newsletter – getting it right at the border 14 08 25 Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA – Border Trade Newsletter – getting it right at the border 14 08 25

Getting it right at the border  This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: IPAFFS Scheduled Update - 14 August Lumpy skin disease: import of animal by-products from France,…
Ben Kemp
August 21, 2025