Welcome to another blog in our ongoing series, Ask Lewis Bass!

This series features actual submitted questions from companies in the industries we provide engineering safety consulting services to.

Topics covered include those associated with our work in 3rd party field labeling, SEMI S2/S8/EMC/F47 testing and design, CE Marking evaluations, and general engineering safety consulting questions. We can even help assist you with your local AHJ and their requirements for evaluating unlisted equipment in your city.

Question:

Hi Lewis Bass,

Is CE self-declaration something that we can perform for our own products or is it a requirement for third party inspection to issue a CE mark on our behalf?

Asked by Gerald in Santa Clara, CA

Lewis Bass:

Gerald, it really depends on what type of product you are manufacturing for shipment to your European customers.

Without knowing the specifics of the machinery/product you are manufacturing I cannot give a definitive answer.

According to the European Union’s official website covering this matter under the question “do you need an independent assessment?” it is stated that:

You need to check if your product has to be tested by a notified body. You can find this information in the relevant legislation applicable to your product: check the rules by product category.

This step is not obligatory for all products.

If you need to involve a notified body, the CE marking must be accompanied by the identification number of the notified body. The CE mark and the identification number can be affixed separately, as long as they appear clearly linked to each other.

When it comes to CE self-declaration it is not always requirement for 3rd parties to be involved, however, most every business engaged in shipping machines to the EU usually contracts with an experienced company like Lewis Bass or a NRTL to have this work performed.

Check out the following excerpt from export.gov here below to see why this 3rd party audit typically applies:

Most products covered by New Approach Directives can be self-certified by the manufacturer and do not require the intervention of an EU-authorized testing/certifying company called a notified body. To self-certify, the manufacturer must assess the conformity of the products to the applicable directives and standards.

The bolded part of this statement is the key component: you would need to have in your employment a capable engineer to assess the machine against the CE directives that the machine must be evaluated against and that is what Lewis Bass and NRTLs do—in addition to preparing the paperwork and technical file for the evaluated equipment.

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