EU - Draft Renewal of RoHS Exemption for Use of Lead in Specific Medical Devices

​The European Commission received an application on December 12, 2018 for renewal of the exemption for 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.

After the public consultation and a technical and scientific assessment study, it concluded that old design MRI devices depend on lead-containing MRI components and are highly limited in their compatibility with new lead-free MRI components.

It further concluded that lead-free models of non-integrated MRI coils are already available. However, as concerns MRI devices with integrated coils, the techincal development and the approval procedure to develop lead-free solutions require additional time.

In order to provide compatible MRI equipment for health services and to allow time for the development of lead-free alternatives, the exemption entry 27 is proposed to be renewed with a revised scope by adding two more points and the new proposed expiry date as follows:

(c) 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] or 

(d) MRI devices including integrated coils, which are used in magnetic fields within the sphere of 1m radius around the isocentre of the magnetic in medical magnetic resonance imaging equipment, for which the Declaration of Conformity issued for the first time before June 30, 2024.

Expires on June 30, 2027

This draft act is open for feedback for 4 weeks until February 9, 2022.