Electro-medical devices: Environmental regulation on hazardous substances

Abstract

In this study, we summarize the drastic restrictions introduced in the last eight years within the European environmental legislation governing electro-medical devices, and highlight manufacturer's obligations to demonstrate compliance with these rules. On July 1, 2011, the recast of the Directive on the Restriction of the use of certain Hazardous Substances in electrical and electronic equipment (known as RoHS II) was published in the European Official Journal. This Directive, that within its scope, included medical devices (MDs) and in-vitro diagnostic medical devices (IVDs), aimed to limit the amount of six toxic materials released into the environment through discarded electrical and electronic equipment (EEE). MDs and IVDs had to be RoHS II compliant from July 22, 2014 and July 22, 2016 respectively. On June 4, 2015, the EU Commission published RoHS III, a new Directive that limited the content of four additional substances belonging to the phthalates group. According to RoHS III, phthalates will be subject to restriction for all EEE, starting from July 22, 2019, with the exception of MDs and monitoring and control equipment which will need another two years. RoHS II is a CE marking Directive; therefore, manufacturers must adhere to its requirements both in technical documentation and in subsequent EU declaration of conformity before affixing the “CE” mark on their finished products. RoHS III is also a CE marking Directive that medical device manufacturers will have to apply starting from July 22, 2021. Although this seems a long time, manufacturers need to start meeting the RoHS III requirements by now to avoid the risk of being out of business for that date.