CE REP questions about our devices ROHS compliance

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
Our CE Rep is asking for detailed information about our devices ROHS compliance. We have two components to our device a battery and a small circuit board. The battery has ROHS testing and I sent the test report to them. The circuit has very sensitive IP fo r our company and that report we cant send them. Can I create a letter stating we are ROHS compliant?

We are CE marked from our NB.
 
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CharlieUK

Quite Involved in Discussions
#2
I presume that you fall under RoHS as a Medical Device, or IVD, and are not exempt as an active implantable medical device
Assuming you're in scope:
What you need to provide to your rep depends on whether you have made them an "authorised representative" and what tasks you have contracted them to perform.
If you, the Manufacturer, are outside Europe then the importer has obligations under Article 9 of RoHS - the level of information they wish to see is really up to them, as they need to feel happy that the product complies.
You should already have included RoHS on you DoC - you appear not to have done so, which would trigger alarm bells, and perhaps request for more information than a piece of paper which is only signed when requested.
I don't mean to sound harsh, and I make no comment on what you have done, but a number of companies do little or nothing and people with experience of that can be wary
 
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