HCL's Integrated Approach for Hazardous Substances in Medical Devices Regulated by EU | HCL Technologies

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The EU regulations restrict the use of various substances, but the approaches used to phase out hazardous substances are very different. Clearly, the intent of all directives is to control the use and disposal of substances that are hazardous to human health or to the environment. From design to disposal of Medical Devices, these directives impose regulations on an OEM’s products over their entire lifecycle, and impact the OEM’s supply chain, customers, distributors and dealers. The European Union’s Restriction on the use of certain Hazardous Substances (RoHS3) Directive 2015/863 amends Directive 2011/65/EU (also known as EU RoHS 2), REACH Regulation 1907/2006, Medical Devices Regulation (MDR) 2017/745/EU and IVDR 746/2017 directives which have significant compliance and financial implications for companies wanting to market their products (Medical Devices) in Europe.