Originally Posted by Bunny
I work for a medical device manufacturer in the US, we want to sell our product into Europe and need to get a better understanding of RoHS and WEEE regulations. I have looked at this site and found some relevant threads and documents. But I was wondering if there was more to know. Especially regarding medical device compliance. Is it true that medical devices do not yet have to comply?
Can someone help me understand what medical device manufacturers have to do to demonstrate compliance? Can someone provide useful tips about how we can implement a process that ensures we RoHS compliant components? Do we need a COC with each receipt of electron components?
Thank you in advance.
In the current RoHS directive 2002/95/EC Medical Devices and Control Equipment are excluded from the RoHS scope (Categories 8 & 9 as defined within the WEEE directive).
In other words, yes you do not have to comply with the current RoHS restrictions yet.
BUT, currently the European Parlement is preparing a recast for RoHS, which is expected to come into force in 2012.
Currently the idea is that the recast will also include Medical Devices and Control Equipment.
So maybe you want to prepare yourself already for this recast.
Nevertheless, if you want to find out more about RoHS and the recast, please visit:
http://ec.europa.eu/environment/waste/weee/legis_en.htm
Here you can find all the official documents.
Originally Posted by somashekar
Hii Bunny.
As I understand it is true that medical devices do not yet have to comply.
You may want to look into
www.bomcheck.net and understand more.
With regards to BOMcheck... this application has been developped by SIEMENS and Environ and is more related to the REACH legislation than to RoHS.
I'm not saying that BOMcheck will not be able to cover RoHS as well, because there is a RoHS module in it, but BOMcheck is a "supplychain communication
tool" but it will not give you the official documents on RoHS.
I guess that with the information that you will find on the official Eu website, you will find all necessary answers.