RoHS CE Mark - Medical Devices built for US before 22 July 2014

M

meddevsd

#1
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:
  1. 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?
  2. 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.
  3. Do we need to officially apply for the exemption, or is the memo enough documentation to be in compliance?
I appreciate your feedback and guidance.

Regards,
 
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bio_subbu

Super Moderator
#3
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:

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?
In case products are RoHS compliant because uses of banned substances are all covered by exemptions, such products can be sold in EU as long as the comply with the requirements of all applicable legislation. In this case RoHS should be added to the DoC (Declaration of Conformity) and the Technical File. Moreover all the procedures requires by the Medical Device Directive have to be fulfilled as well.

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.
The technical file should indeed specify that the use of banned substances is covered by a specific exemption.

Do we need to officially apply for the exemption, or is the memo enough documentation to be in compliance?
The exemption has been published on the Official Journal of European union directives, so it is now law and valid for anybody. In case you use the exemption you just need to specify in the technical file that you are using it in your product to explain the presence of lead in solders.
 
P

Penny007

#4
Hello All

I have some 320 exemptions coming under RoHS EXEMPTION .So is it OK that I can use all these exempted components till the date they expire?
Are there any stringent requirements that I need to document regarding these exempted components?

Your inputs will be very helpful.

Regards
PN:bigwave:
 
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