- Clarification of the scope of the Directive and related definitions:
- Inclusion of medical and monitoring equipment in the scope of ROHS;
- Addition of an 11th category of products, i.e., other electrical and electronic equipment not covered by the previous 10 categories of products;
- Selection of four toxic and hazardous substances (DIBP, DEHP, DBP and BBP) as candidates for restriction, although no new restricted substances were added. - Incorporation of ROHS compliance for electrical and electronic equipment into CE marking requirements.
Medical devices controlled by ROHS 2.0 include:
- Devices that utilize electrical energy and meet the definition of a medical device in EU Directive 93/42/EEC;
- Devices that utilize electrical energy and meet the definition of an in vitro medical device in EU Directive 98/79/EC.
- Devices that work with electrical energy and meet the definition of an extracorporeal medical device in EU Directive 98/79/EC.