EU - A new RoHS exemption proposed regarding the usage of lead in certain medical devices

​Certain hazardous substances are restricted in electrical and electronic equipment (EEE) under the RoHS Directive. Specific, time-limited exemptions can be granted upon request from businesses if the necessary criteria are met.

This initiative concerns a request for an exemption for lead in polyvinyl chloride (PVC) used as base material in sensors which are used in in-vitro diagnostic medical devices. 

‘41a. Lead as a thermal stabilizer in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of creatinine and blood urea nitrogen in whole blood. Applies to category 8 and expires on ​December 31, 2023.’​​

This draft act is open for comment for 4 weeks until February 13.