In June, the European Parliament issued a recast of the Restriction of the Use of Certain Hazardou

In June, the European Parliament issued a recast of the Restriction of the Use of Certain Hazardous Substances (RoHS) in Electrical and Electronic Equipment Directive (Directive 2011/65/EU) that now includes medical devices and in vitro devices (IVDs) among the equipment under its purview. The RoHS directive now boasts its own listing of categories (Annex I) subject to the directive. The RoHS directive previously had linked to the Waste Electrical and Electronic Equipment (WEEE) Directive (Directive 2002/96/EC) and the categories of products subject to RoHS delineated within the WEEE directive.

Annex II of the RoHS directive bans electronic equipment with maximum concentration values exceeding 0.1 percent of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls or polybrominated diphenyl ethers from entering the EU market. European Union parliamentarians recast the RoHS directive to minimize legal disparities between member states in terms of restrictions on hazardous materials in electrical products; without a more uniform RoHS approach, trade barriers and competitive distortions could arise within the EU marketplace.

“It therefore appears necessary to lay down rules in this field and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste EEE (electrical and electronic equipment),” the new directive states. The recast directive also is intended to encourage manufacturers to use safer materials in place of restricted substances.

Interestingly, while the RoHS directive is not part of the EU’s “new approach” directive, the recast RoHS directive requires CE marking affixed to the product to demonstrate compliance and defines the roles and responsibilities of the key economic operators: manufacturers, importers and distributors.