Re: REACH for Medical Devices
for medical devices, article 33 of reach (european directive 2006/1907/EG) is applicable
this means you have to inform your customers of any substances that are on the candidate list of Substances of Very High Concern (SVHC)
basically you research your BOM and identify any substances used
then make a reach statement declaring whatever substance is used
if you use power cables or other cables, chances are they use DEHP as plasticizer
example letters can be found from dell, hp and many others
i used a form that i send to suppliers of parts to inform us about any substances and made up a statement for our customers
many ignore this and tell use reach is not applicable but when we explain about article 33 they come up with statement, just have to push them to go up their chain