Exemption Filing / Exemption Justification

Hello Everyone,

I have got this issue related to my ongoing work.

1. The scenario is as below:
2. A medical device manufactured in Europe.
3. It is not CE marked
4. Now the company wants the device to be RoHS 2 compliant before 22nd july 2014.

There are some 294+ electrical components which are declared exempted by their suppliers in Declaration of conformity(DoC).
Is there a need to provide justification to the concerned authoriy/communicate with end user(i.e customer) ,that the components used are RoHS 2 and REACh compliant.?
If yes , what is the appropriate way to do so.
If not, then how shall I prove that device is RoHS/REACh compliant.

Kindly provide your valueable anwers!!

Help is appreciated!!

294+ electrical components which are declared exempted by their suppliers in Declaration of conformity(DoC).

Click to expand...

Exempted for what ?

Hi Somashekhar,

294+ components are exempted for use under 7C -1 of RoHS 2 directive.
In short shud I need to provide justification for the usage of these exempted components.
Or is ther some other task involved

See section (18) and (19) in the DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast).
This is in the page (L 174/90)
Your NB should be convinced

Hi Somashekhar,

Thanks for your time!
However Section 18 and 19 do not answer my question.

The doubt is:

When my components are exempted under 7C-1 of RoHS in DoC submitted by component supplier , what kind of document I( must prepare to justify this exemption to a notifying body.

Right now I am zeroing down on one possibility( may be right/wrong ):

• To collect test report of each component from the supplier.
• Know the amount of hazardous substance at the homogenous level of component fromTest reports.
• Calculate the total amount of hazardous substance ( using some empirical formula , which I dont know) in device.
• If it violates RoHS /REACH then notify respective supplier.
• Finally tabulate all the above information and keep in handy to present before notifying body when asked.

Please let me know whether the above approach is right and moreover is it necessary?

If not , then what is the alternative.

If any body could help!!!

Hello All

I have same doubts as of Gargi

Would appreciate if anybody could help

RoHS needs your inputs in the technical file suitably that the NB reviews. (I am not sure if the NB's are authorized for the DIRECTIVE 2011/65/EU also)
When you detail in the technical file of the medical device all the homogenous parts that comprise to form your product, all such 7c-I parts can be so mentioned with what so ever proof of excemption you are supplied with.
Then for the rest, either you support with your supplier certification or test same based on your risk assessment.
You can use a approved test house like the TUV or SGS who will provide you a comprehensive test report considering all the inputs you provide like the 7c-I or 6(c) declarations, etc and where necessary tests are conducted on such other parts, and a report issued.
Based on the report you can make your declaration in your technical file per ANNEX VI of the directive.

Thanks a ton Somashekar !!

I think this is the way I have to proceed !
Once I am finished with this task , Iwould like to prepare an Excel sheet enlisting all different exemption conditions and their solution.

I appreciate that you devoted your time to answer these queries.

Thank you once again

Elsmar Cove Rocks !!!

Thanks for the info Somashekhar

So is it that I can use n number of exempted components in my device and there is no any necessary to justify the use of these exempted components?

And in case of REACH Regulation do i need to justify the lead concentration does not cross 1 ton in exempted components?

Please confirm if I a on the wright track

Regards
Penny

watsuppp