Following the proposal in September 2022, Dechlorane Plus has been included in Annex A (Elimination) to the Stockholm Convention on 15 May. This Annex requests Parties to ‘take measures to eliminate the production and use of the chemicals listed’. In the UK, this falls under the POPs legislation. This information is kindly provided by MedTech Europe.
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Following a consultation on a new RoHS exemption for the use of lead in PVC used as a base material in sensors for IVDs (category 8), the European Commission has adopted its decision, which is for the exemption to expire on 31 December 2023. BIVDA members did not provide feedback on this topic. This information is kindly provided by MedTech Europe.
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MedTech Europe are requesting feedback on Glutaral and associated information. If your organisation uses this substance, we would appreciate your feedback on: The intermediate use definition stated in REACH in relation to Glutaral, and whether is it an appropriate definition What impact would result from the use of Glutaral as a cross-linker or auxiliary in the manufacturing process Members are…
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The EU Framework for Safe and Sustainable by Design is aimed at those researching and manufacturing chemicals and materials. The first reporting period of the Safe and Sustainable by Design (SSbD) framework testing phase is open until 30 June 2023. If applicable, members are invited to fill in the reporting template, which can be found and submitted via this link.…
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MedTech Europe have previously requested information on mercury lamps used in the medical device and IVD sectors. It was noted previously that under RoHS exemption 1(f)-II and 2(b)4-I for neonatal jaundice treatment, we have no uses of mercury lamps in these exemptions. Further information has been requested by LightingEurope as to the reason for this, primarily whether this is due…
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The European Commission adopted an amendment to the CLP Regulation on 25 April. These additions can be summarised as follows: A ‘Note X’ has been added to Part 1, section 1.1.3.1 of Annex VI, which indicates that: ‘The classification of hazard class(es) in this entry is based only on the hazardous properties of the part of the substance which is…
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The restriction proposal for D4/D5/D6 is expected to be discussed within REACH Committees in June 2023. ECHA has proposed derogations for medical technologies, including for certain uses or increased allowable concentrations: Dental impression materials Medical devices for scar and wound management, and stoma care More information can be found on the Silicones Europe website. This information was kindly provided…
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There is work ongoing within MedTech Europe on labelling of medical devices. To support in this work, MedTech Europe have requested the following information from industry by 28 April. Data on financial impact of additional labelling requirements arising from any jurisdiction. Costs of label development/production per major jurisdiction are welcome (e.g. to prepare a specific label for certain region/country; percentage of…
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The joint industry statement on the PPWR Single Market Legal Basis has now been made public. This urges co-legislators to preserve the internal market legal basis for the Packaging and Packaging Waste Regulation as the best way to achieve proposed environmental and economic objectives. The document is planned to be circulated amongst various key stakeholders, including the European Commission. …
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ECHA has proposed to include lead metal under REACH Annex XIV. This proposal excludes the use of glutaral in laboratory reagents in scientific research and development, use in medical devices, and formulation in biocidal products. Members are requested to review the proposal and inform Ashleigh (ashleigh@bivda.org.uk) by 26 April or any concerns affecting your organisation from this proposal. This…
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ECHA has proposed to include lead metal under REACH Annex XIV. A few examples of the uses in scope of the proposed Authorisation are: batteries, ammunition, cables, vehicles, machinery, electronics, radiation shielding, sanitary, construction, art and musical instruments. Members are requested to review the proposal and inform Ashleigh (ashleigh@bivda.org.uk) by 26 April if there are any uses that would fall…
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MedTech Europe are conducting a survey to understand compliance to REACH article 33(1). Specifically, they are requesting: Do you list information on your companies website for compliance (Y/N)? Do you send information to the recipient of the article (Y/N)? Is this information provided in other means (Y/N)? If yes, which methods is this done (labeling on the product, in the…
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There is an ongoing public consultation on priorities under the Ecodesign for Sustainable Products Regulations (ESPR). This consultation is open until 12 May. It is possible that this could affect certain medical devices such as adult incontinence products or substances used in production of medical devices and IVDs. Members are encouraged to review this consultation and provide feedback directly by…
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