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Manufacturers of electrical and electronic equipment will be faced with two new European directives that are intended to better protect the environment. The WEEE and RoHS Directives have different implications on medical devices.
The Waste of Electrical and Electronic Equipment (WEEE) Directive has taken effect as of August 13, 2005. From that moment on producers of this equipment are responsible for the correct processing of their products that have reached the end of their operational life. Moreover, they must be able to demonstrate in advance that they have the financing of the collection and processing fully organized and under control.
Until now it’s not clear if medical devices will remain to be subjected to this directive. At this point only implants and infected products are excluded. The Directive is not applicable to devices placed on the market before the implementation date, nor to the spare parts installed into these older devices.
Own interpretation
The challenge with this directive is that nowhere at the European level have the procedures been established as to how a manufacturer must comply with the directives. By way of comparison, such conformity procedures for CE Directives have been put down on paper and a producer that has stood the test of criticism, may sell its products on the entire European market. In the case of the WEEE, however, every individual member state has to give its own independent interpretation. Manufacturers therefore have a tremendous need for information about the implementation per country’, Gert Bos, product manager medical certification at KEMA says.’To meet this need, KEMA is putting together a summary of the legislation, registration, recycling, and financing for each individual member state. Via www.kema.com (type WEEE report -fulltext search- in the search box) you can order the WEEE report.
Not subjected to RoHS
The Restriction on Hazardous Substances (RoHS) Directive becomes effective in mid-2006. This directive forbids the use of lead, mercury, cadmium, chromium, and bromine in electrical and electronic products. An exception will be made for medical and testing equipment. As a consequence medical devices will not be subjected to the RoHS.
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