ROHS DIRECTIVE AND MEDICAL IMAGING DEVICES (2006-2021) Lessons learned and a closer look on benefits and impacts

After 7 years from the first proposal of inclusion of medical devices, COCIR decided to look back to evaluate the real costs and impacts entailed by RoHS for the medical imaging sector, and the real benefits in terms of reduction of the use of hazardous substances. COCIR also decided to look forward to 2021 to estimate costs and benefits of the recently published amendment to Annex II of RoHS, introducing 4 phthalates to the list of banned substances.
The results of the evaluation of the reduction of the use of RoHS substances are presented in Chapter 4. It is estimated that only 2,4% of the RoHS substances have been removed as a result of including medical devices in scope, while 97,6% is actually covered by exemptions, as no alternatives are available. In 2021, the percentage of substitution would reach 13% in the most optimistic scenario.