On April 10th 2015, two new EU Restriction of Hazardous Substances exemptions were published in the Official Journal of the EU.
These two new exemptions, along with the expiration dates, are applicable to “Medical devices” and “Monitoring and control instruments including industrial monitoring and control instruments” category 8 and 9 of the Annex IV to RoHS Directive 2011/65/EU.
Are you aware of what substances and until when their usage was exempted? Check it out below!
New exemptions: What are they for?
The Commission Delegated Directive (EU) 2015/573 officially adds the exemption for lead:
“Lead as a thermal stabiliser 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 blood and other body fluids and body gases. Expires on 31 December 2018”
Commission Delegated Directive (EU) 2015/574 officially adds the exemption for mercury:
“Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation. Expires on 30 June 2019”
Be RoHS Compliant!
The RoHS Directive 2011/65/EU lays down provisions on the restriction of the use of certain hazardous substances in all electrical and electronic equipment (EEE). Medical device manufacturers are required to be in compliance with the RoHS Directive from:
•22nd of July 2014 for Medical Devices.
•22nd of July 2016 for In-Vitro Diagnostic Medical Devices.
•23rd of July 2019 for all other EEE
If you want to know more about RoHS compliance, please contact Us