Industry
In order to minimise the quantity of hazardous substances entering the waste stream from Electrical and Electronic Equipment (EEE), the Restriction of Hazardous Substances (RoHS) Directive places obligations on manufacturers to avoid the use of certain substances in equipment. However, these hazardous substances in certain applications provide a critical engineering functionality for essential equipment, such as that produced by the medical imaging equipment sector.
Medical imaging equipment, ranging from X-ray, MRI, and CT to ultrasound, provides crucial, non-invasive, and early detection of diseases, significantly improving diagnostic accuracy and patient outcomes. The RoHS Directive allows the hazardous substances to be used where there is no technical alternative, for time limited periods known as exemptions.
The European Commission reviews applications by interested parties seeking to continue using the hazardous substances, to determine whether their use is justified.
RINA supports the trade association, COCIR, in assessing if the hazardous substances restricted under RoHS are still technically necessary for the performance of medical imaging equipment. Where these substances represent the only viable technical option, we assist COCIR in justifying their continued use of substances through exemption renewal applications. We gather evidence on the technical performance of the substance in the equipment, together with an analysis of potential alternatives and socioeconomic impact, to put forward a robust case for the necessity of its continued use. Additionally, we contribute to the clarification question process to ensure effective engagement throughout the exemption assessment.
We have assisted COCIR, as well as other trade associations, individual companies and lead consortia, in over 50 exemption renewals, and we have also contributed to requests aimed at revoking exemptions.
Through RINA’s assistance, COCIR has ensured that medical imaging devices can continue to be placed on the EU and UK markets. We support the periodic review of exemptions, ensuring that, where no alternative substances are available for critical medical imaging equipment, these devices can continue to be supplied to healthcare systems until feasible substitutes can be implemented.
