Skip to Menu Skip to Search Contact Us Taiwan Websites & Languages Skip to Content

10 April 2015, the European Commission announced two amendments to Annex IV of medical devices, and monitoring and control instruments of Directive 2011/65/EU (RoHS 2.0). It shall enter into force on the twentieth day.

In Annex IV to Directive 2011/65/EU, the following point 41 & 42 are added:

Amended exemptions
Exempted uses
Expires time
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
(EU) 2015/573
Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50MHz) modes of operation.
Expires on 30 June 2019
(EU) 2015/574

Contact Window

Taipei Multi Chemical Laboratory
ADD: No. 125, Wu Kung Road, New Taipei Industrial Park, Wu Ku District, New Taipei City, Taiwan 24886
TEL: +886-2-2299-3279 Ext. 3103~3129
FAX: +886-2-2299-3237

Kaohsiung Multi Chemical Laboratory
ADD: No. 61, Kai-Fa Road, Nanzih Export Processing Zone, Kaohsiung, Taiwan 81170
TEL: +886-7-301-2121 Ext. 4101~4106
FAX: +886-7-301-0867