EU Rule Sets Higher Standard For Medical Devices

Law360, New York (July 28, 2014, 10:51 AM EDT) -- Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (also known as the "RoHS-2 Directive"),[1] adopted in 2011, replaced the original 2003 "RoHS-1" Directive.[2] The RoHS program is aimed at restricting hazardous substances in electrical and electronic equipment ("EEE") so as to contribute to the protection of human health and the environment.[3] With the adoption of the RoHS-2 Directive, the program's substantive requirements and scope expanded considerably. The RoHS-2 Directive now imposes chemical restrictions, conformity assessment, CE-marking requirements and postmarketing surveillance obligations on manufacturers, importers and distributors of EEE....

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