The recast Restriction on Hazardous Substances (RoHS) (Directive 2011/65/EU) appeared in July 1, 2011 edition of the Official Journal of the European Union. The recast directive now includes medical devices that are also electrical and electronic equipment.
The directive applies to medical devices placed on the market after July 22, 2014 and in vitro diagnostic devices placed on the market after July 22, 2016. The directive does not apply to active implantable medical devices.
A manufacturer prepares technical documentation demonstrating that design and manufacture of the product satisfies the requirements of the RoHS directive. The manufacturer prepares a declaration of conformity (Annex VI specifies the required elements) and retains both documents for ten years after placing the product on the market.
The limits in the directive create maximum concentration value by weight in homogeneous materials. Annex II lists the materials and their limits. Annex IV lists some medical device applications exempt from the restrictions.
Hexavalent chromium 0.1%
Polybrominated biphenyls (PBB) 0.1%
Polybrominated diphenyl ethers (PBDE) 0.1%
You can download the directive from the Official Journal at