Restricted substances EU MDR

Medical Devices placed on the EU market must comply with both the Medical Devices Regulation (MDR) 2017/745/EU and the Restriction of the use of certain Hazardous Substances (RoHS) Directive 2011/65/EU and its amendments. Both include substance restrictions but the approaches used are very different. The medical industry has complied with the RoHS Directive since 2014 and report that this is very costly financially as well as administratively in terms of time occupied by employees who would otherwise be developing new medical technology.