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 KempAugust 28, 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 KempAugust 28, 2025
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 KempAugust 28, 2025
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 KempAugust 22, 2025
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 KempAugust 22, 2025
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 KempAugust 21, 2025
The new CLSI NBS11 - Newborn Screening for Congenital Adrenal Hyperplasia, provides laboratories with clear recommendations for using dried blood spot specimens to perform newborn screening (NBS) for congenital adrenal hyperplasia (CAH). This newly released standard covers the full testing process, including preanalytical, analytical, and postanalytical phases, as well as both short-term and long-term follow-up considerations.
Ben KempAugust 21, 2025
Although the below update is specific to drug trials it includes information of when sponsors need to make Change notifications/submissions which includes when there are changes to technical equipment used during the trial, or when there are changes to diagnostics used to monitor the trial. Join our Route B substantial modification pilot A Route B substantial modification refers to a…
Ben KempAugust 21, 2025
Dear members, Health Canada, have updated the eSTAR pilot, expanding the scope of submissions. View article...
Ben KempAugust 21, 2025
Upcoming EU active substance renewal submission deadline Apply for active substance renewal by the deadline to keep products on the NI market. 27 August 2026 Citric acid (CAS 77-92-9 EC 201-069-1) in product type 2
Ben KempAugust 21, 2025