On December 12, 2018, the Commission received an application for renewal of the exemption – The use of lead in newly designed non-integrated MRI coils and in upcoming lead-free MRI devices with integrated coils should be excluded from the exemption with specific dates. Not granting the renewal request could result in premature wastage of MRI devices due to a lack of compatible components or redesigning options. This could result in a supply gap of MRI equipment, which could in turn adversely affect health care for patients. The total negative environmental, health and consumer safety impacts of substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof. The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (the REACH Regulation) and thus does not weaken the environmental and health protection afforded by it. Therefore, in Annex IV to Directive 2011/65/EU (RoHS Directive), in entry 27, the following points (c) and (d) are added: ’27 ‘(c) MRI non-integrated coils, for which the Declaration of Conformity of this model is issued for the first time before September 23, 2022, or (d) MRI devices including integrated coils, which are used in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, for which the Declaration of Conformity is issued for the first time before June 30, 2024. Expires on June 30, 2027.’
EU – RoHS Exemption for the use of Lead in Certain Magnetic Resonance Imaging Devices
