Our white paper provides a detailed overview of changes within the new Restriction of Hazardous Substances Directive (2011/65/EU), which has undergone major changes in terms of scope, definitions, and newly introduced methodologies and procedures.

As a medical device manufacturer, importer or distributer, it is important to understand and fulfill the obligations of the RoHS 2 Directive, especially now that manufacturers must demonstrate compliance to RoHS in the Technical Construction File to support CE marking. This paper highlights and explains the main changes of the Directive and discusses its impact on the industry.

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