RoHS 2 – Medical Devices and other Electrical and Electronic Equipment affected by RoHS Recast

Since July 22nd, 2014, the European Restriction of Hazardous Substances Directive (RoHS) also applies to medical devices and monitoring and control instruments which are new on the market.

RoHS regulates the use of certain hazardous substances in electrical and electronic equipment and parts. With RoHS the European Union wants to optimize the manufacturing and corresponding recycling of the rapidly changing products in the electrical and electronic industry. The first RoHS Directive 2002/95/EC (“RoHS 1”) which came into force on July 1st, 2003, has been replaced by the RoHS Directive 2011/65/EU (“RoHS 2”, “RoHS Recast”) which came into force on January 3rd, 2013.

Amongst other things, the Directive describes when the scope of RoHS 2 will be expanded to which new to market product categories in the years ahead:

  • since July 22nd, 2014: medical devices and monitoring and control instruments

  • from July 22nd, 2016: in vitro diagnostic medical devices

  • from July 22nd, 2017: industrial monitoring and control instruments

  • from July 22nd, 2019: other electrical and electronic equipment which is not covered by any of the categories listed in RoHS 2 (e.g. charging devices for car batteries, interruption-free power supplies)

As need-based, adaptive software solution, the  iPoint Compliance Agent (iPCA) also supports our customers in complying with the RoHS 2 Directive. The Compliance Agent can be adjusted to the relevant new directives and ensures an automated and secure exchange of relevant information across the whole value chain.

You'll find more information on RoHS/RoHS 2 here:

  • Medical Equipment Affected by RoHS Directive From 2014

  • Medical Devices to Be Affected by RoHS Directive in 2014

  • Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011