Dear Members, please see below update from MedTech Europe on the EU situation regarding the proposal to include MCCP (Medium Chain Chlorinated Paraffins), used as a flame retardant, in the EU POP (Persistent Organic Pollutants) regulation. This will impact devices placed on the NI market as well as the UK market, but as MCCP would be added under the Stockholm…
Ben KempJuly 4, 2025
Dear members, please see the DEFRA Circular economy newsletter, if not for those members putting self-test devices on the UK market, the packaging extended producer responsibility fees have been decided for the different materials. Medical device packaging, which is not recyclable qualifies for a derogation under the RAMS modulation, which means that the base fee (amber band) will be charged…
Ben KempJuly 4, 2025
Climate-related transition plan requirements Page summary: We’re seeking views on options to take forward climate-related transition plan requirements in order to provide the market with credible and decision-useful information. Change made: First published. Time updated: 1:00pm, 25 June 2025 Climate Innovation Forum 2025: keynote speech by Ed Miliband Page summary: Secretary of State for Energy Security and Net Zero, Ed…
Ben KempJuly 4, 2025
SEPA have been posting water scarcity updates, and in some areas are prompting businesses to consider planning accordingly. Water scarcity | Beta | SEPA | Scottish Environment Protection Agency 26 June 2025 | Beta | SEPA | Scottish Environment Protection Agency
Ben KempJuly 4, 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: Foot and Mouth Disease in Austria Lumpy skin disease in Italy Sheep pox and…
Ben KempJuly 4, 2025
Dear members, please see below MedTech Europe Update, another busy week with the items below highlighted as having previously been identified as potentially used by the MD/IVD sectors. Let me know at regulatory@bivda.org.uk if any of the highlighted items are in your products. Dear members, We hope you are all well. With this email, we would like to inform you…
Ben KempJuly 4, 2025
Please note the changes to Scottish legislation to introduce offences under Packaging and Packaging Waste regulations. The Environmental Regulation (Enforcement Measures) (Scotland) Amendment Order 2025 This Order amends the Environmental Regulation (Enforcement Measures) (Scotland) Order 2015 (“the 2015 Order”) so as to specify offences under the Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024 as relevant offences under the…
Ben KempJuly 4, 2025
Dear members, please see MedTech Europe update to the ECHA chemicals update last week, MedTech Europe have reviewed the listed chemicals and have noted that a number are on their horizon scanning substance tracker list, as being used in the MD/IVD sector. Please review and let me know if these substances are used in your products Dear members, We hope…
Ben KempJune 26, 2025
ECHA Virtual assistant to support stakeholders We are testing an AI-based virtual assistant on our support pages to improve navigation and access to relevant information. We are currently testing this initial version for accuracy and relevance. We invite stakeholders to explore the assistant and provide feedback directly through the platform to help us enhance the service. Learnings and recommendations…
Ben KempJune 26, 2025