The European Commission is planning to lift a July 22, 2019 deadline and allow certain second-hand and refurbished devices that contain hazardous substances to continue to be marketed in the EU beyond that date.
The EU’s 2011 Directive on the Restriction on the Use of Certain Hazardous Substances (RoHS2) prohibits non-compliant electronic medical devices, IVDs, and industrial monitoring and control instruments that were already on the market before specified dates from being marketed after July 22, 2019.
The ban would greatly restrict the availability of second-hand and refurbished devices, according to attorney Cándido García Molyneux at Covington & Burling.
The RoHS2 Directive prohibits importation and marketing of electronic medical devices and other equipment that contain the hazardous chemicals. The ban took effect on July 22, 2014 for electronic medical devices and electronic monitoring and control instruments.
A similar ban on electronic IVDs took effect on July 22, 2016. A ban on electronic industrial monitoring and control instruments containing hazardous chemicals will take effect on July 22, 2017.
The Commission is expected to formally introduce the proposed amendment to the directive early this year. It will need approval by the European Parliament and the Council of the European Union.