MedTech Europe Updates Environmental Newsletter – Page 8

Safe and Sustainable by Design (SSbD) framework testing phase – deadline 30 June European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

Safe and Sustainable by Design (SSbD) framework testing phase – deadline 30 June

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.…

adminMay 12, 2023

Feedback request 10 May: RoHS mercury lamps European Chemicals Agency Updates Environmental Newsletter European Chemicals Agency Updates Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

Feedback request 10 May: RoHS mercury lamps

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…

adminApril 28, 2023

Amendment made to EU CLP Regulation European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive Uncategorized

Amendment made to EU CLP Regulation

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…

adminApril 28, 2023

Derogations proposed for D4/D5/D6 European Chemicals Agency Updates Environmental Newsletter European Chemicals Agency Updates Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

Derogations proposed for D4/D5/D6

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…

adminApril 28, 2023

Request for information on labelling BIVDA Updates Environmental Newsletter BIVDA Updates Environmental Newsletter Archive BIVDA updates Regulatory Affairs Newsletter BIVDA Updates Regulatory Affairs Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive MedTech Europe Updates Regulatory Affairs Newsletter MedTech Europe Updates Regulatory Affairs Newsletter Archive

Request for information on labelling

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…

adminApril 21, 2023

Joint industry statement on the PPWR Single Market Legal Basis Industry newsletters Environmental Newsletter Industry Newsletters Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

Joint industry statement on the PPWR Single Market Legal Basis

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. …

adminApril 21, 2023

ECHA has proposed to include glutaral under REACH 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 has proposed to include glutaral under REACH

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…

adminApril 14, 2023

ECHA has proposed to include lead metal under REACH 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 has proposed to include lead metal under REACH

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…

adminApril 14, 2023

MedTech Europe survey on REACH Art. 33 compliance MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

MedTech Europe survey on REACH Art. 33 compliance

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…

adminMarch 31, 2023

Public consultation on proposed Ecodesign for Sustainable Products Regulation (ESPR) European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive European Commission Updates Regulatory Affairs Newsletter European Commission Updates Regulatory Affairs Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive MedTech Europe Updates Regulatory Affairs Newsletter MedTech Europe Updates Regulatory Affairs Newsletter Archive

Public consultation on proposed Ecodesign for Sustainable Products Regulation (ESPR)

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…

adminMarch 17, 2023