Review of the RoHS Directive

MedTech Europe welcomes the opportunity to provide feedback to the open public consultation on the revision of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS).

MedTech Europe supports the objectives of RoHS to protect human health and the environment. RoHS has been a successful tool in reducing the presence of hazardous substances in electrical and electronic equipment (EEE). Medical technologies which fulfil the definition of ‘electrical and electronic equipment’ (EEE) are regulated by RoHS under Category 8 (medical devices & in vitro diagnostic medical devices).

This public consultation is an opportunity to reflect on the successes and challenges the medical technologies sector has faced with RoHS and to suggest ways to address those to ensure a smooth supply of medical technologies to users, whilst complying with the legislative requirements set out in RoHS. Our recommendations would acknowledge the specificities of the medical technologies sector, improve the efficiency for the Commission and industry, whilst supporting health and environmental protection.

For more details, please see MedTech Europe’s position paper on the revision of RoHS.