MedTech Europe – BIVDA Newsletter

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Request: Feedback on Glutaral

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…

TeheljMay 19, 2023

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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…

AshleighApril 28, 2023

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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…

AshleighApril 28, 2023

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…

AshleighApril 28, 2023

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…

AshleighApril 14, 2023

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…

AshleighApril 14, 2023

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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…

AshleighMarch 31, 2023

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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…

AshleighMarch 17, 2023

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EU MDR/EU IVDR amendment approved by EU Council

On 7 March, the European Council unanimously approved the amendment to the EU MDR and EU IVDR. This amends the transitional provisions for the MDR and removes the sell-off provision for IVDs. This is expected to be published in the Official Journal of the European Union this month, which will be when it comes into force. MedTech Europe's press release…

AshleighMarch 9, 2023

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MedTech Europe survey results: Transition to the IVD Regulation

MedTech Europe have published their Survey Report Transition to the IVD Regulation - MedTech Europe Survey Results for October 2022. This report can be found on the MedTech Europe website. The results demonstrate that there are still bottlenecks occurring throughout the IVDR implementation, and indicates where additional attention is needed.

AshleighMarch 9, 2023