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

Impact of EU batteries regulation on UK medical/IVD device manufacturers

Med-Tech Innovation have published an article explaining how the new EU Batteries regulation may affect UK medical device manufacturers: In July 2023, the EU adopted the hotly anticipated Regulation (EU) 2023/1542 on batteries and waste batteries (Batteries Regulation). The Regulation, which replaces the former Batteries Directive, marks a step change towards achieving the EU’s climate neutrality goal by 2050. Batteries…

adminFebruary 14, 2024

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Mandatory Sustainability Reporting in China

China’s three major stock markets, the Shanghai Stock Exchange (SSE), Shenzhen Stock Exchange (SZSE), and Beijing Stock Exchange (BSE) have published new sustainability reporting guidelines for listed companies. These reporting requirements for companies covers 4 topics - governance, strategy, impact, risk and opportunity management, and indicators and goals. The listed topics indicate that the exchanges are adopting a “double materiality”…

adminFebruary 14, 2024

Chemical Watch Updates Environmental Newsletter Chemical Watch Updates Environmental Newsletter Archive Upcoming Events Environmental Newsletter Upcoming Events Environmental Newsletter Archive

Chemical Watch training: Navigating Chemical Management in China

Chemical Watch are hosting an online course on the Introduction of Chemical Management Regulations in China on 27 February. This training provides essential insights into China's chemical management regulatory framework, facilitating market entry. Members who are interested in joining this training are requested to register using this link.

adminFebruary 14, 2024

European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive

CIRPASS project conference

CIRPASS project is funded by the European Commission under the Digital Europe Programme, which is a collaborative initiative to prepare the ground for the gradual piloting and deployment of a standards-based Digital Product Passport (DPP) aligned with the requirements of the Proposal for Ecodesign for Sustainable Product Regulations (ESPR), with an initial focus on the electronics, batteries, and textile sectors.…

adminFebruary 14, 2024

EU RoHS exemption pack timelines

MedTech Europe have kindly provided EU RoHS exemption pack timelines. Packs 22 & 27 These Packs include: Annex III lead exemptions: 6(a) series*, 6(b) series*, 6(c)*, 7(a)*, 7(c)-I*, 7(c)-II*, 13(a), 13(b), 15, 18(b), 34, 42, 44 Annex III cadmium exemptions: 8(b), 13(b) Annex IV lead exemptions: 1(a), 1(b), 1(c), 4, 10 Annex IV cadmium exemption: 9 Annex IV DEHP exemption:…

adminFebruary 14, 2024

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Health Canada: Draft guidance on how to interpret ‘significant change’ of a medical device

This guidance document has been updated to expand on the definition of "significant change" in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant. Health Canada have a updated the Guidance on how to interpret ‘significant change’ of a medical device in order to expand…

adminFebruary 14, 2024

EU REACH 12th draft recommendations for substances to be added to Annex XIV (Authorisation)

ECHA have launched a consultation on its 12th draft recommendation of substances to be added to the REACH authorisation list (Annex XIV). Currently, the substances included in the draft recommendation are: Melamine (EC-No.: 203-615-4; CAS: 108-78-1) Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (TBPH) (EC-No: n/a; CAS: n/a) S-(tricyclodeca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl…

adminFebruary 14, 2024

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

Various pieces of EU and UK legislation amended

Multiple EU and UK legislative changes have taken place recently. Notably, these include changes to: EU legislations: Commission Implementing Decision (EU) 2023/2723 of 6 December 2023 on harmonised standards for electrical equipment drafted in support of Directive 2014/35/EU of the European Parliament and of the Council: Note: IVDs are outside of the scope of the low voltage directive, however members placing…

adminFebruary 14, 2024

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BSI webinar on the impact of the EU AI Act

BSI are hosting a webinar about updates on the EU AI Act progress, covering its history, the significant elements of the recent December deal, and its potential impact on various industries on 27 February. The webinar will include an explanation on EU AI Act and strategies to prepare for the Act's implementation. Members who are interested in attending this webinar…

adminFebruary 14, 2024

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Swissmedic weekly update (WC 12 Feb)

Please note this is an extract of the original bulletin. swissdamed – Swiss Database on Medical Devices The “going-live” date being deferred to the 2nd half of 2024

adminFebruary 14, 2024