MedTech Europe Updates Environmental Newsletter Archive – Page 6

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

Final MTE Microplastics clarification question

MedTech Europe have submitted to ECHA a request for clarification questions on the EU REACH restriction on synthetic polymer microparticles. Please see attached. Once they have received the answers, these will be shared with members. MTE Chemicals WG will work on labelling and pictogram suggestions, regarding how to identify affected IVD products that contain microplastics. Please send any feedback you…

Ben KempSeptember 4, 2024

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

Revised F-Gases label format adopted

Dear members, please see below message from MedTech Europe regarding the EU F Gas Regulation, and publication of the labelling implementation legislation. Dear members, With this e-mail, we would like to inform you that the Commission draft delegated act on the updated format for F-gases labels has been adopted on 2 September. The act is available at the link here.…

Ben KempSeptember 4, 2024

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EU F Gas regulation

An update regarding the EU F Gas regulations that apply in the EU and in Northern Ireland. F gases are fluorinated gases used as refrigerants, in heat pumps, air conditioning, but also covers anaesthetics, all of which are significant greenhouse gases much more potent than carbon dioxide. In the revised EU regulation, some categories of devices that use/contain F Gases…

Ben KempAugust 28, 2024

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

ECHA weekly substance consultations – deadline 30 August

Please provide feedback on the consultations below, if they affect you, so we can pass this information on to MedTech Europe. Please let us know by 30 August. Harmonised classification and labelling consultations: 4-hydroxy-4-methylpentan-2-one; diacetone alcohol (EC 204-626-7, CAS 123-42-2); and 8-methyldecan-2-yl propionate; 8-methyldecan-2-yl propanoate (EC -, CAS 81931-28-4). Proposal to harmonise classification and labelling: reaction products of ammonium bromide…

Ben KempAugust 27, 2024

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MedTech Europe Response to the Public Consultation on the EU POPs Regulation Implementation of UV-328

MedTech Europe have submitted the attached information, to the EU consultation (Persistent organic pollutants - UV-328 (europa.eu)) on inclusion of UV-328 under the Stockholm Convention on Persistent Organic Pollutants. UV-328 is a UV blocker commonly used to prevent degradation of materials such as plastics. The UK is also a signatory to the Convention, So I’m sharing the MedTech Europe response…

Ben KempAugust 27, 2024

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For input by 6 Sept: RoHS Annex III Pb & Hg exemptions

Dear Members, MedTech Europe are gathering information on the EU RoHS (including Norther Ireland), exemption pack renewal for Lead and Mercury in product type 8 – medical devices include those specifically for IVDs. If you rely on the exemption packs for RoHS compliance to place products on the EU and/or Northern Ireland markets then please let BIVDA me know. MedTech…

Ben KempAugust 21, 2024

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MedTech Europe Sustainability and Environmental Flash Report May 2024

MedTech Europe have provided Sustainability and Environmental Flash Report. Please note this is an extract of the MedTech Europe's original bulletin. “Embrace. Innovate. Collaborate.” These are core recommendations from three dedicated sustainability panel sessions held at MedTech Forum 2024. The session “The Climate Crisis-Our next Health Crisis?” identified, among other, education, incentives, an enabling framework for innovation and collaboration as…

adminJune 5, 2024

European Chemicals Agency Updates Environmental Newsletter European Chemicals Agency Updates Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

ECHA recent substance developments

Based on the weekly ECHA updates, the recent substance developments include: REACH: Bis(2-methoxyethyl) ether (Diglyme): ECHA published a screening report to assess whether the use of this substance in articles should be restricted. creosote and creosote related substances: ECHA published the compiled opinion of RAC and SEAC on the restriction proposal for this substance. Stilbenesulfonic acid ditriazine dyes: ECHA published…

adminMarch 6, 2024

MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

MedTech Europe Sustainability and Environmental update

Please note this is an extract of the original bulletin. Corporate Sustainability Due Diligence Directive update The Directive on corporate sustainability due diligence was nearing the adoption of the CS3D text by the end of 2023 through the agreement reached between the European Parliament and the Council. The rules were aimed at fostering sustainable and responsible corporate behaviour and to…

adminFebruary 28, 2024

ECHA calls for evidence for proposal to ban UV-328

UV stabilisers commonly found in plastics are: UV-328 (EC: 247-384-8; CAS: 25973-55-1), UV-327 (EC: 223-383-8; CAS: 3864-99-1), UV-350 (EC: 253-037-1; CAS: 36437-37-3), UV-320 (EC: 223-346-6; CAS: 3846-71-7) ) After its inclusion into Annex A to the Stockholm Convention, ECHA opened a call for comments and evidence for UV-328. This consultation closed on 18 August 2023. ECHA published its screening report…

adminJanuary 31, 2024