Is it possible to use RoHs 6c exempted components in a PCB which will be used in medical device?

Elo012345

Registered
My company develops medical device (not implantable or not for diagnosis). Some electronic boards uses connectors which are compliant with the RoHS with exemption 6c. Is it an issue? Is it necessary to change these components?
If the final electronic board is compliant to the RoHS (even with theses components), is it necessary to justify the use of theses components?
 

CharlieUK

Quite Involved in Discussions
Your product is RoHS compliant when it has no restricted substances above permitted limits and you can apply any exemptions that are general to all products or specific to your end product application.

Any exemptions you have applied should be explained in your Technical Documentation, but don't go on the DoC
 

Elo012345

Registered
Thanks for your answer. It's really helpful.
The component is a connector, the only information provided is that it is 6c RoHS exempted, How do we know with accuracy the % of restricted subtances for our final product without the exact % of restricted substance for this connector?

Why is it not necessary to explain the exemptions on the DoC?

I read this information, could you please confirm that it's true?
"RoHS exemption 6c was due to expired on July 21, 2021 for equipment categories 8. Some applications for an extension of the exemption were submitted in time. For this reason, exemption 6c will remain valid until the EU Commission has decided."
When can we expect feedback from the commission on this exemption?
Thank you again,
 

CharlieUK

Quite Involved in Discussions
The limit is for the homogenous materials in each and every component - RoHS compliance is "built up" from all the individual components within a product.
EN IEC 63000:2018 provides guidance on whether or not you accept a declaration of the component supplier as sufficient evidence, or carry out additional testing.
The required contents of the DoC are given in Annex VI and there's no requirement to list the applied exemptions.
There's no date as of yet as to when the Commission will complete review - keep an eye on RoHS Directive
 
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