By Stewart Eisenhart, Emergo Group
A revised Waste Electrical and Electronic Equipment Directive (WEEE2, 2012/19/EU) will expand recovery and recycling targets for electronic medical devices in the European Union.
Eucomed Environment Consultant Andy Vaughan writes that starting August 13, 2012, medical equipment falling under the “Large Equipment” and “Small Equipment” product categories of WEEE2 will have to meet recovery targets of 70% and recycling targets of 50%. Those percentages will increase to 75% for recovery and 55% for recycling in August 2015, and then 85% and 80% for “Large Equipment” devices starting in August 2018 once new equipment categories are added to the Directive. (“Small Equipment” devices’ recovery and recycling requirements will remain at 75% and 55%, respectively, in 2018.)
Medical device manufacturers may also face new requirements under WEEE2 regarding shipping across national borders in the EU, according to Eucomed. Specifically, manufacturers will have to prove their devices being shipped across borders are functional and not illegally shipped waste products.
Once WEEE2 goes into effect, EU member states must complete their transpositions of the Directive no later than February 14, 2014. What this means for medical device manufacturers subject to WEEE requirements must be examined, as these changes will be significant. At least the industry has some time to work out the ramifications.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.