The design, manufacture and shipping of electrical medical devices in the European Union could soon become more challenging because of new and proposed changes to the Restriction of Hazardous Substances Directive (RoHS) and Waste Electrical and Electronic Equipment Directive (WEEE). Instead of seeing these directives as inconveniences, the medical device industry should embrace them, writes Andy Vaughan in a blog post for Eucomed.
From about April/May 2014, medical devices will fall within the scope of RoHS. Complying with RoHS can be complicated and will most likely require reviews of production training and redesign of some circuit boards, Vaughan writes. Proposed changes to the WEEE directive, which medical devices already fall under, could also result in challenges to the industry. One of the proposed changes involves restrictions on the shipping of electrical and electronic equipment across national borders. In the future, shipping these types of equipment could require evidence that it is working, or the equipment could risk being classified as waste. While these changes could result in challenges to the medical device industry, it would be ironic if the industry did not embrace regulations that could make people healthier, says Vaughan in his article.
“WEEE and RoHS are both aimed at stopping hazardous substances from entering the environment where they can pollute causing disease in humans and other species. We should welcome that. As I see it the medical technology industry should be leading the way. Mustn’t we, who produce devices to improve people’s health, also ensure that we are not contributing to people’s ill health in the process?” writes Vaughan.
The blog post “WEEE & RoHS: the dynamic duo that wants to keep people healthy” can be found on the Eucomed website.Camilla Andersson