MedTech Europe Updates Environmental Newsletter – Page 4

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

EU Chemicals update Inc. Biocides decision regarding Ethylene Oxide

Dear members, MedTech Europe have provided an update below on the latest chemical developments at ECHA. Please note that Ethylene Oxide has been declined as an active substance under the Biocides regulation for PT 2, however use of Ethylene Oxide to sterilise medical devices within the scope of EU MDR means that the use of Ethylene Oxide can continue as…

Ben KempJune 18, 2025

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EU POPs Regulation update – UV-328

Dear Members, please see the following update from MedTech Europe on the draft EU POPs Regulation regarding UV-328. It would appear that we will see some divergence in the requirements between the EU and UK, with the EU legislation applying to products placed on the NI Market. Dear members, We are writing to inform you that the revised draft delegated…

Ben KempMay 9, 2025

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For information: ECHA 2025-2027 Work Program

MTE would like to share for your information the ECHA 2025-2027 work program that was released on 29 January 2025, which contains an overview of topics it will focus on and the respective resources it will require to carry out these tasks (link). For our work, below are a few interesting points to note: Topics: REACH and CLP These two…

Ben KempFebruary 7, 2025

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For information: Consultation submissions: Microplastics & Non-Animal Testing

MedTech Europe has published two position papers. One of the reporting requirements for microplastics (approx. less than 5mm, although there is also a spec for filaments) reporting requirements and the other on the phase out of animal testing. Microplastics Reporting Requirements - link Non-Animal Testing - link

Ben KempJanuary 24, 2025

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MedTech Europe Sustainable Corporate Governance Working Group – OECD (BIAC) Sustainability Reporting Survey

Please see below an email from the OECD (BIAC) Secretariat. They are asking for feedback to their ongoing survey on Sustainability Reporting experiences and challenges, you can find more information below in case you would like to participate. The deadline is the 30th January. In support of Business at OECD (BIAC)’s ongoing special project on “The Risks of Divergence between…

Ben KempJanuary 24, 2025

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PPWR: Council adopts final Regulation

MTE update on the EU Packaging and Packaging Waste Regulation. MTE has worked hard for specific derogations (contact sensitive packaging) and extended timelines to address the issue of packaging traceability, and the need for the recycling market (specifically plastics (chemical) recycling ) to mature and meet sector requirements. To: STC, Circular Economy WG and TF PPWR Dear members, Please be…

Ben KempDecember 18, 2024

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EU RoHS update

Dear members, Please see below update we have received from MedTech Europe regarding the proposed inclusion of TBBP-A and MCCP in the scope of EU RoHS. I hope you are all well. We would like to share an update with you regarding the status of the inclusion of TBBP-A and MCCP in RoHS. A few years ago, as part of…

Ben KempDecember 18, 2024

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REMINDER: MedTech Europe Sustainable Corporate Governance Working Group: CSRD PREPAREDNESS SURVEY

Please see a reminder for the following survey: MedTech Europe are conducting a survey on member preparedness for obligations under the EU CSRD (Corporate Sustainability Reporting Directive), which requires companies to report against the European Sustainability Reporting Standards (ESRS). Corporate sustainability reporting - European Commission EUR-Lex- 02013L0034-20240528 - EN - EUR-Lex CSRD reporting applies to all large companies,…

Ben KempNovember 27, 2024

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New Guidance (MDCG 2024-13) on the Qualification of Ethylene Oxide for Medical Device Sterilization

An update from MedTech Europe on the newly published MDCG guidance mdcg 2024-13 regarding (Ethylene Oxide (EtO) used to sterilise MD and IVDs. It clarifies the status of EtO as not being under the Biocides Regulation (where it would have been banned), but falling under the MDR/IVDR, but not in itself being a medical device. Dear Members, We are…

Ben KempNovember 1, 2024

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For information: European Ombudsman report on REACH Authorisation delays

Regarding EU REACH Authorisations for substances of very high concern. Of note are the two recommendations below, which could directly impact applicants requesting authorisation. Applying the rule that it is up to applicants to demonstrate that they have satisfied the legal conditions for obtaining the Authorisation by providing sufficient information, Ensuring that applications containing insufficient information are promptly dismissed, so…

Ben KempOctober 25, 2024