Getting The Lead Out: Firms Need To Remove The Metal From Devices In EU By 2014

Article preview from "The Gray Sheet"-  August 27, 2012

The European Commission revised the Restriction of Hazardous Substances in Electrical and Electronic Equipment directive last May, and expanded its scope to include medical devices and in vitro diagnostics sold in the EU within the next two to four years.

 Getting The Lead Out: Firms Need To Remove The Metal From Devices In EU By 2014

Article preview from "The Gray Sheet"-  August 27, 2012

A recently revised European Union directive requires device makers to replace the commonly used metal lead in electronic equipment with a less toxic alternative by the summer of 2014. That is no trivial task, say device experts, and companies should already be figuring out how to comply.

The European Commission revised the Restriction of Hazardous Substances in Electrical and Electronic Equipment directive last May, and expanded its scope to include medical devices sold in the EU on July 22, 2014, and in vitro diagnostics on July 22, 2016.

“The RoHS directive has the potential to make your life difficult,” said Andy Vaughan, an environmental consultant for European device trade group Eucomed. “It is a good idea if you are a manufacturer of devices that you are going to sell into the EU to assess the situation with regard to RoHS now because complying with RoHs may not be at all straightforward.”

Medical devices and diagnostics were excluded from the original directive that took effect in 2006. However, the revised directive is not retroactive and therefore will not apply to devices or diagnostics that were sold in the EU before the 2014 and 2016 implementation dates and are already in use on the market.

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