Healthcare Technologies Resource Guide - Export.gov

The material has to be sourced from approved plants and the process has to be documented. For more
information, please contact the Foreign Agricultural Service at the U.S. Mission to the European Union.
Environmental Requirements
Growing mountains of waste of electrical and electronic equipment have forced the EU to consider ways
to reduce, recover and recycle packaging and appliances. Also, the use of hazardous substances has led
to environmental damages; therefore, certain substances such as lead or mercury have been banned.
Those issues have been tackled by the Waste of Electrical and Electronic Equipment Directive (WEEE) and
the Restriction of Hazardous Substances in Electrical and Electronic Equipment Directive (RoHS).
Medical devices will fall under the scope of the RoHS directive in the future (3 years after entry into force
of the text for medical devices, 5 years after entry into force of the text for IVDs). Others laws such as the
Waste Electrical and Electronic Equipment (WEEE) directive require OEMs to dispose of products they
manufacture in an environmentally responsible way once the equipment reaches end of life. Medical
devices are covered by this directive but with a specific exemption today for “implanted and infected
medical devices.”
For more information, please visit export.gov/europeanunion/weeerohs.
Chemical Substances and Mixtures in Medical Devices
Medical devices containing or consisting of chemical substances and mixtures are subject to specific
requirements under the Registration, Evaluation, Authorization and Restrictions of Chemicals (REACH)
Regulation and the Classification, Labeling and Packaging of substances and mixtures (CLP) Regulation.
REACH entered into force on June 1st, 2007. It changes the former legislative framework for chemicals
to ensure a high level of protection of human health and the environment. REACH makes industry
responsible for assessing and managing the risks posed by chemicals and providing appropriate
safety information to their users. Under REACH, the EU can also take measures to ban the use of highly
dangerous substances. CLP aligns previous EU legislation on classification, labeling and packaging of
chemicals to the UN GHS (Globally Harmonized System of Classification and Labeling of Chemicals).
U.S. Commercial Service Healthcare Technologies Resource Guide | 2012–2013
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