Re: What needs to be done to demonstrate RoHS compliance for Medical Devices ?
Pls help me understand what needs to be done to demonstrate compliance to RoHS Compliance for Medical devices ?
Also, is this applicable only for devices sold into Europe ?
Does your medical device already carry a CE mark... and is notified with a NB...
I assume so.
I may be a bit different but this must work for you.
RoHS is applicable to EEE Medical devices.
It is a CE mark directive.
RoHS compliance will have to be demonstrated through a technical file, that the NB reviews and approves to continue use of CE mark
There will be only one CE mark and you have it already ....

))
Ask your NB how he would want the Technical file to be updated to contain RoHS information and RoHS test certification, and follow guidelines provided by the NB. Make your RoHS declaration as given in the new directive and include it in your technical file.
As far as possible and practicable, get your suppliers to declare the supplied parts as RoHS in line with the declaration that you find in the new RoHS directive, and make this a part of your technical file. Make a risk based assessment to get any parts tested yourself and include same in the technical file.
If you have planned well, you are not far from being good within the 2014 timeline.... Cheers
