Stay Of Execution In EU For Environmental Shortfall Devices

Cándido García Molyneux is quoted in a Medtech Insight article regarding an expected amendment to the Directive on the Restriction of Hazardous Substances (RoHS2). According to García Molyneux, if proposed, non-RoHS compliance electronic medical devices, IVDs and control instruments may be further supplied in the distribution chain or resold after July 22, 2019 even if the deadlines for the ban on import and first marketing have passed. This imposition of the 2019 deadline, he says, would severely restrict the continued supply of new devices that are still in the supply chain, as well as the resale and second-hand market of used, repaired or refurbished devices.