Electrical and Electronic Equipment (EEE) can contain a variety of hazardous materials that will ultimately be released into the environment via landfill. The Restriction of Hazardous Substances Directive (RoHS) (2002/95/EC) requires that, with a few exceptions, lead, mercury, cadmium, hexavalent chromium and two flame retardants, PBB and PBDE must not be used in electrical and electronic equipment.
This regulation has meant that manufacturers of EEE have had to seek alternatives to, amongst other things, the traditional lead/tin solder for making electrical connections and for use in flow-soldering machines for printed circuit boards. Many manufacturers have had to completely re-equip their assembly lines and repair workshops in order to comply.
This has also resulted in many electronic components designed for use with lead solder being made obsolete, forcing medical device manufacturers to use 'lead-free' components earlier than required by law.
The current RoHS Directive exempts ‘medical devices‘ from its requirements, however the RoHS Directive was ‘recast’ in July 2011 and in January 2013 Directive 2002/95/EC will be replaced by Directive 2011/65/EU, which will include medical devices within its scope from 22 July 2014 and IVD devices from 22 July 2016.
Our Environmental Systems Specialist can help you:
  • Keep up-to-date with developments concerning extension of the RoHS requirements to medical devices

  • Identify alternative materials

  • Develop standard design codes of practice to cope with the new requirements

Contact us for more information on how GEMARMED can help you meet the EU RoHS requirements, or to talk with our Environmental Systems Specialist.