Dear members, please see below MedTech Europe update on EU REACH and CLP. If you have these substances in your products that you place in the EU or Northern Ireland markets, please let us know. We would like to inform you on the latest news from ECHA and ask you for your input and feedback on recent REACH and…
Ben KempSeptember 11, 2024
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
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
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
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
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
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
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
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