RoHS exemption for use of lead in medical devices is approved by the European Commission

A seven-year extension, valid until 30 June 2027, to the exemption for the use of lead in medical equipment under the EU Directive on the Restriction of Hazardous Substances (RoHS) has been approved by the European Commission.

On 12 December 2018, the European Commission received an application for renewal of the exemption for the use of lead in medical devices. In 2020 an application submitted by the European Coordination Committee of Radiological, Electromedical and Healthcare IT Industry demanded the extension of the exemption till 30 June 2027.

The exemption covers the use of lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors that are used in certain medical ‘Magnetic Resonance Imaging (MRI) equipment. 

The result of technical and scientific studies, and public consultation show that older-design MRI devices are limited in quantity and highly dependent upon lead containing components compared to new lead-free versions. Although non-integrated lead-free MRI models are available, concerns are that it will require additional time to develop a lead-free integrated MRI solution. The lack of redesigned models can create a supply gap, which could affect healthcare for patients.

The exemption entry 27 in Annex IV is proposed to be approved for renewal in order to provide MRI equipment for medical services in a compatible manner and to permit the time to be taken for development of lead-free devices. Two points are added in the exemption proposal as follows -

• MRI non-integrated coils, for which the Declaration of Conformity of this model is issued for the first time before [the date of publication in the Official Journal of the Delegated Directive + 1 day]
• MRI devices including integrated coils, which are used in magnetic fields within the sphere of 1m radius around the isocenter of the magnetic in medical magnetic resonance imaging equipment, for which the Declaration of Conformity issued for the first time before 30 June 30 2024.

Superconductor 

Due to the lack of lead-free alternative devices on the market with properties such as ductility and electrical resistivity at low temperature, the Commission has also renewed an exemption for the use of lead in Bismuth Strontium Calcium Copper Oxide (BSCCO) superconductors for use in cables and wires, and lead in related electrical connections for other Electrical and Electronic Equipment (EEE) components. 

Lead-doped BSCCO is used to:

• create superconducting magnetic circuits for medical devices and monitoring and control instruments
• achieve higher resolution images for medical diagnosis or research and stable operation mode of the relevant applications

According to the EU RoHS Directive, the EU member states must adopt and publish the necessary legislation by 28 February 2023. 

The renewed exemption expires on 30 June 2027.