Ben Kemp – Page 85 – BIVDA Newsletter

Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

For information: Weekly ECHA Substance Evaluations

Dear members, please see below update on the weekly ECHA bulletin. If your impacted by the issues below, let me know at regulatory@bivda.org.uk With this email, we would like to inform you about the latest chemicals developments at ECHA: Publication of the Assessment of Regulatory Needs reports for the following substance groups: Aliphatic esters from branched carboxylic acids and branched…

Ben KempAugust 22, 2025

Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

For review: EU Restrictions Roadmap – Revised June 2025

Please see the below MedTech Europe Update on ECHA’s proposed Restriction roadmap. Note that this will impact products placed on the EU and Northern Ireland markets. If you impacted by the proposals to restrict use of these chemicals, please let me know via regulatory@bivda.org.uk As previously discussed evidence of the impact and lack of available alternatives has been key in…

Ben KempAugust 21, 2025

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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 KempAugust 21, 2025

Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

For information: Lead value chain support on Lead Metal CLP Classification

Please see below update from MedTech Europe on the harmonised Classification and labelling of Lead. If you use Lead metal or Lead powder or associated substances please find the below information that applies to products placed on the EU and NI markets. We would like to share a recent communication from the Lead manufacturers (International Lead Association), which aims to…

Ben KempAugust 21, 2025

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Just Released: CLSI NBS11: Guidance for Newborn Screening of Congenital Adrenal Hyperplasia

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

Environmental Newsletter Environmental Newsletter Archive European Chemicals Agency Updates Environmental Newsletter European Chemicals Agency Updates Environmental Newsletter Archive

ECHA Weekly: Updated PFAS restriction proposal published

Updated PFAS restriction proposal published We have published the updated proposal to restrict per- and polyfluoroalkyl substances (PFAS) under the EU’s chemicals regulation, REACH. The update has been prepared by the authorities from Denmark, Germany, the Netherlands, Norway and Sweden, who submitted the initial proposal in January 2023. The five authorities have completed their evaluation of the more than 5…

Ben KempAugust 21, 2025

Environmental Newsletter Environmental Newsletter Archive European Commission Updates Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter

MTE Update on D4/D5/D6 Siloxanes

Dear Members, please update from MedTech Europe on the proposal to nominate D4/D5/D6 Siloxanes under the UN Stockholm Convention on Persistent Organic Pollutants. We are writing to share with you an important update with regard to D4/5/6. We have recently understood that the European Commission has withdrawn its intention to nominate D4/5/6 as a POP under the Stockholm Convention on…

Ben KempAugust 21, 2025

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MHRA – Announcing our Route B substantial modification pilot

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

Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

Important: Updated PFAS Restriction Proposal

Dear members, please see below update on the progress of the proposed PFAS restriction under EU REACH which will also impact Northern Ireland. We are writing to inform you that today, ECHA published the updated PFAS Restriction proposal (link). This is an important milestone, as this updated proposal, reveals all changes that the Dossier Submitters (Denmark, Germany, Netherlands, Norway, and…

Ben KempAugust 21, 2025

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The eSTAR pilot: Notice to industry

Dear members, Health Canada, have updated the eSTAR pilot, expanding the scope of submissions. View article...

Ben KempAugust 21, 2025