Starting July 22, 2014, the European Union will be requiring medical devices and products to comply with the Restriction of Hazardous Substances (RoHS). Whether or not you are currently removing trace materials from your products or are exploring this possibility as a medical device manufacturer, doing so will soon be standard practice.
The most recent revision of RoHS compliance, RoHS Recast, introduced a broader definition to include any device that uses electrical currents or electromagnetic fields to accomplish a function. In their article, Mark Leimbeck and Anwen Evans provide an overview of the directive, while Geoffrey Bock provides an an extensive (although not complete) list of devices that may be impacted.
With a little over 60 days left before the effective date, wiring and cable manufacturer Northwire has outlined 10 critical requirements to ensure CE-mark compliance. As of July 22, 2014, the provisions of RoHS 2 will apply to Category 8, medical devices, and Category 9, monitoring and control instruments. Originally published in 2011, the RoHS Recast Directive is a multi-phase directive that includes further medical and monitoring devices that are impacted at a later date.
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