Devices & Diagnostics

Medical devices subject to new hazardous materials laws in EU

New hazardous materials regulations in the European Union will include medical devices, which were previously exempt from certain laws governing electronic devices. The EU’s new “Restriction of Hazardous Substances Directive” (RoHS), which regulates materials in electrical and electronic equipment (EEE), will significantly impact the medical device field, according to a BSI healthcare eUpdate. The new […]

New hazardous materials regulations in the European Union will include medical devices, which were previously exempt from certain laws governing electronic devices.

The EU’s new “Restriction of Hazardous Substances Directive” (RoHS), which regulates materials in electrical and electronic equipment (EEE), will significantly impact the medical device field, according to a BSI healthcare eUpdate.

The new regulations are designed to improve collection and recycling of electronic devices and to reduce illegal exports of such waste from the EU.

The automatic exclusion from RoHS will disappear for all medical devices and in vitro diagnostic devices soon, according to the BSI. The RoHS previously did not apply to the devices, will remain in place for active implants. Medical devices, as well as monitoring and control instruments, must comply within three years and IVDs must comply within five years of the new regulation’s adoption.

The European Parliament adopted the “consolidated text” for RoHS recast late in 2010, and the final step to approve legislation in the Council of the European Union “is very near,” BSI reported.

The Council in March took formal steps on revised EU rules for disposing of electric and electronic equipment such as mobile phones and household appliances, according to a statement (PDF) from the organization.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.

Topics