The Exemption for Medical Devices Under the RoHS Directive Has Expired

The RoHS Directive 2011/65/EU, Article 4 (3) exclusion for industrial monitoring and control instruments expired on Saturday, July 22, 2017. That exclusion was used by quite a few manufacturers to delay RoHS compliance, but Article 4 (3) is now gone. This means that any industrial monitoring and control equipment must now comply with the RoHS Directive 2011/65/EU, just like the Low Voltage Directive 2014/35/EU and the EMC Directive 2014/30/EU in order to place a CE marking on it.

The RoHS Directive must also be indicated on the EU declaration of conformity for the equipment. We note that RoHS applies to everything in the equipment and if questioned you may be required to hand over a Technical File to show compliance of everything in your product, including the paint and labels. F2 Labs can prepare a Technical Report to show RoHS compliance, using the sole harmonized RoHS standard, EN 50581:2012 Technical Documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances. F2 Labs is here to help. Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.