According to the EU Directive on the control of dangerous substances, the European Commission has renewed an exception for a particular use of lead in medical equipment (RoHS). An exemption for seven years (June 30, 2027) was requested by the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry through renewal application. The seven-year extension began June 30, 2020. The usage of lead covers the following areas:

Healthcare

Components used in some medical magnetic resonance imaging (MRI) equipment, such as solders, termination coatings for electrical and electronic components, printed circuit boards, connections for electrical lines, shields, and enclosed connectors.  

An evaluation report of the renewal request stated that Older MRI devices rely on lead-containing components and are not compatible with newer lead-free types and the lead-free device development and certification processes take longer for integrated coil devices. Without renewal extension, the only way to discard the older MRI devices. However, that could lead to a shortage of MRI equipment and threaten patient care.

Superconductor 

The Commission has extended an exemption to Sumitomo Electric Industries for the use of lead in BSCCO superconductors for use in cables and wires as well as lead in related electrical connections to other electrical and electronic equipment (EEE) components. The updated exemption runs out on June 30, 2027.

Superconducting magnetic circuits for medical, monitoring, and control devices are built using lead doped BSCCO. According to the evaluation report, there is no lead-free substitute on the market that offers application reliability. Lead is inevitably required to provide both technological and functional benefits.

By 28 February 2023, EU member states must implement and publish the relevant legislation in accordance with the revised Directive. The Commission announced in July that it had postponed the release of its proposal on the modification of RoHS while it reviewed REACH and considered the proposed regulation on Eco-design for sustainable products.

Reference: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022L1632
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022L1631


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