M
meddevsd
Hello,
We are a medical device company taking the RoHS exemption 2014/13/EU -for mobile medical device class IIb- that extends the deadline to 2020, allowing for lead solder only on populated circuit boards. The questions we have are:
Regards,
We are a medical device company taking the RoHS exemption 2014/13/EU -for mobile medical device class IIb- that extends the deadline to 2020, allowing for lead solder only on populated circuit boards. The questions we have are:
- Product built in the US for US and other countries not requiring RoHS compliance, before July 22, 2014, and stocked in the US, can be sold after July 22, 2014 bearing the CE mark?
- Is the 2014/13/EU Exemption requiring RoHS Compliance with DoC and also documenting the acceptance of exemption? -we have issued an internal memo or "design note" to document our justification for taking the exemption, as well as our interpretation of the exemption. This document will be linked to our technical file.
- Do we need to officially apply for the exemption, or is the memo enough documentation to be in compliance?
Regards,
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