Self Certification for CE. 1

[madhudc]

Hello,
I have a couple of questions on the Self Certification procedure:

1. In the Declaration of Conformance document, do the Security Standards tested have to be listed also, apart from the emissions and conductance standards.

2. Can a Company Self Certify for CE under the following conditions:
* The testing of the product to be certified, by a 'Notified Body', resulted in failure to pass in certain aspects.
* The Notified Body recommended some changes to the product, so that it may pass the test next time.
* The Company has noted those recommendations and has implemented those to the product.
* The modified product was sent for re-testing for CE.
* The Company is running out of time for release of the product to the market and goes ahead to Self Certify the product for CE. The Technical Construction File at this point will contain the previous failed test report and another document explaining the modifications made to the product in order to make it pass (of course, one can't be 100% certain that the product will pass the test this time).
* Once the final test reports arrive, saying that the product has passed the test, the Company simply modifies the documentation in the Technical Construction File.
There is a need to meet a deadline by the Company to market the product, but the question is, "Is this a legal way of going about things?"

Thanks for your help.

 

[ccaserta]

Unfortunately the only legal way is to conform. If there is a deadline and you are not compliant and time prohibits you from showing conformance it is best to wait until the testing is complete. If you ship your product and the test fails again it will be necessary to pull your products or make the corrections in the field. If making the corrections in the field is a solution for you then you can roll the dice and take a shot at getting through customs. As long as you have the right documentation there shouldn't be any problems. I strongly recommend you make the final corrections when the time comes.

Good Luck Christopher Caserta
ccaserta@us.tuv.com
Ph:904-225-0360

 

[buzzp]

Technical, it is legal as long as the product passes the required tests AND a Notified Body is not required for your particular device.

 

[ccaserta]

I agree buzzp self certification is fine, it sounds like they have found a fix but haven't gone for retesting. Based on the conditions listed conformance has not been shown by the manufacture. Christopher Caserta
ccaserta@us.tuv.com
Ph:904-225-0360

 

[madhudc]

Thanks a bunch people. It really helps. I had not been able to pin point in my documentation [the gazillion documents for CE!] that without conforming, we can't go ahead with the Self-Certification. Now I have better backing to prove my point to my seniors.
Thanks,
madhudc.

 

[buzzp]

It is worthwhile to note that you can market the product just not sell it until it passes the required tests. You must clearly identify this in any literture or inform the marketing group to make this well known, upfront. Trade shows and such are fine, just do not sell any until the tests are passed.

 

[stephenweinstein]

You did not say whether the involvement of a notified body was required or you decided to voluntarily use a notified body for testing. This is probably a factor in determining the answer.

What seems logical to me (and is therefore probably wrong, since laws are so rarely what seems logical to non-lawyers) is:

If using a notified body was not required in the first place, then bringing the product into conformity and self-certifying seems reasonable. If using a notified body was required and self-certification alone is not adequate, then self-recertification after failure would probably not be adequate either.

 

[stephenweinstein]

Regarding the comment that "without conforming, we can't go ahead with the Self-Certification":

Some Directives make a distinction between the verbs "comply" (which means to satisfy every requirement of the Directive) and "conform" (which means to meet a standard).

In all cases, you must "comply" with the "Directive". For CE, you are not required to "conform" to the "standard", unless the Directive says that you are. (However, in some cases, conforming to the standard may be required for other markings, such as UL.)

If the "Notified Body" tested whether the product "conformed" to the "standard" and found that it did not, but the product does "comply" with the "Directive", then you probably can self-certify, unless the "Directive" indicates otherwise.

However,
1) you cannot self-cerify if you do not comply with the "Directive" (whether or not you "conform" to the "standard")
2) you cannot self-certify if the Directive requires certification by a notified body
3) you cannot self-certify if you do not conform to the standard AND the Directiive requires you to either comform to the standard or obtain certification by a notified body
4) you cannot self-certify if you do not conform to the standard AND the Directive requires you to conform to the standard