RoHS – BIVDA Newsletter

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ECHA: New RoHS exemption for lead in PVC used in IVD devices added to ANNEX IV

On 24 July 2023, the European Commission published a RoHS amendment to include a new exemption under Annex IV that comes into effect 13 Aug 2023. The exemption applies to lead used as thermal stabilisers in PVCs for sensors which are used within in vitro diagnostic (IVD) medical devices. The exemption is granted for a limited period of time, which…

TeheljSeptember 15, 2023

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Outcome of consultation on RoHS exemption for the use of lead in PVC

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.

TeheljMay 19, 2023

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RoHS use information requested – deadline 26 May

Recently, BIVDA joined the Joint Trade Association, a collective of Trade Associations in the electronic space. This is in response to ongoing pressure with UK RoHS and the new fee associated with submitting applications of exemption under UK RoHS. We hope that by working with JTA, we will be able to support the BIVDA membership in submitting, or collating, UK…

AshleighMay 5, 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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Recent Chemical Watch summary

Neil Plumridge (Chair of the Environmental Working Party) has provided the following summary of recent Chemical Watch developments. In order to access links, you will need an account with Chemical Watch. UK The UK Health and Safety Executive’s (HSE) practice of sending ‘quality observations’ to UK REACH registrants following dossier evaluations – rather than a more detailed draft decision –…

AshleighApril 28, 2023

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OPSS weekly update (WC 20 Mar)

Please note this is an extract of the original bulletin. Regulations: restriction of hazardous substances (RoHS) Page summary: Guidance for manufacturers, importers and distributors. Change made: Notifications guidance and form updated.

AshleighMarch 31, 2023

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Recent Chemical Watch summary

Neil Plumridge (Chair of the Environmental Working Party) has provided the following summary of recent Chemical Watch developments. In order to access links, you will need an account with Chemical Watch. EU CLP revision proposal published Dec 2022, includes new delegated acts as well as changes to the regulation. The delegated acts introduce new hazard classes (Endocrine Disruptors, PBT/vPvB…

AshleighMarch 24, 2023

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DEFRA weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. The use of lead and cadmium in ion selective electrodes Page summary: Seeking your views on an application to exempt the use of lead and cadmium in ion selective electrodes from the RoHS Regulations. Change made: We added the government’s response to the consultation. Businesses approved to export to the…

AshleighMarch 17, 2023

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Recent Chemical Watch summary

Neil Plumridge (Chair of the Environmental Working Party) has provided the following summary of recent Chemical Watch developments. In order to access links, you will need an account with Chemical Watch. UK Northern Ireland will continue to apply EU REACH rules under the new ‘Windsor Framework’ deal Prime Minister Rishi Sunak has signed with the European Commission, the UK’s Department…

AshleighMarch 9, 2023

OPSS weekly update (WC 20 Feb)

Please note this is an extract of the original bulletin. Restriction of hazardous substances (RoHS) exemptions for electrical and electronic equipment: how to apply Page summary: How to apply for an exemption to use a restricted substance to manufacture electrical and electronic equipment. Change made: From 6 April 2023, you’ll need to pay an administration fee if you apply for…

AshleighMarch 9, 2023