Medical Devices: ROHS 2.0 and other Restricted Substance Requirements
● On July 1, 2011, ROHS 2.0 (2011/65/EU) was officially published in the Official Journal of the European Union and will come into force in 20 days.
● Compared to the original ROHS Directive 2002/95/EC, one of the major changes in ROHS 2.0 is that it includes all electrical and electronic products, including medical devices, in its scope of control.
● Considering the new requirements of ROHS 2.0 for medical devices, the world's leading medical device manufacturers, G and P, have started to investigate and control ROHS and other restricted substances.
The main elements of ROHS 2.0 are as follows:
- 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 products not covered by the previous 10 categories of products.
- Addition of an 11th category, i.e., other electrical and electronic equipment not covered by the previous 10 categories;
- Selection of four toxic and hazardous substances (HBCCD, DEHP, DBP and BBP) as candidates for restriction, although no new restricted substances have been 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 to operate and meet the definition of a medical device in EU Directive 93/42/EEC;
- Devices that utilize electrical energy to operate 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.