A good business move isn’t necessarily easy, especially when the move is overseas. CE marking, which is legally required to sell equipment in the European Union’s 27 member states, Norway, Liechtenstein and Iceland, fits that description. “CE” is an acronym for the French words “Conformite Europeenne” and signifies that a product meets European health and safety requirements. The challenge is identifying and meeting the directives (laws) that apply to your product.
“There is no easy way for U.S. exporters to understand and go through the process of CE marking,” describes the U.S. Department of Commerce.
But it’s often a requirement.
There is no comprehensive list of products that require CE marking, yet it’s a manufacturer’s responsibility to determine if a product requires the marking. Before a manufacturer can affix the CE marking to a product, it must go through a conformity assessment process. The European Commission’s “New Approach Directives” (for sectors such as machinery, electrical products and medical devices) contain the legal requirements to which a product must conform. Export.gov describes that to determine if a product needs CE marking, a manufacturer must look at each directive that is related to the product. Some products require conformance to more than one directive. For example, the Safety of Machinery directive, the Electromagnetic Compatibility directive, and the Low Voltage Equipment directive may apply to one product.
Some directives allow manufacturers to assess their own products and self-certify. That’s the case with all three directives in the preceding example. GSE like pushback tractors and stairs can be self-certified, says Peter Holmgren, a former electronic engineer who’s now in charge of the GSE certifications done by SMP in Sweden. Without deep knowledge of the directives and how they should be interpreted, manufacturers have a tough job, he says. “The directives don’t tell you how the requirements should be fulfilled,” he says. “For that, you need the standards.”
Han Zuyderwijk, whose company (Alura Group in The Netherlands) helps develop CE certification self-help systems, says it’s important to understand the relationship between the directives and the harmonized European standards (EN standards), which are not obligatory. However, he says by complying with the relevant EN standards, products are presumed to comply with the applicable directives. “Because the EN standards provide far more detailed design specifications than the directives, they are much easier to apply and they are a great help in self-certification,” he says, adding that they also change as technology advances.
Directives for “high-risk products” require assessment from independent certification bodies, known as “notified bodies” within the European Economic Area. For example, machines that lift people more than 3 meters above ground require examination by a notified body unless the machines are built according to EN standards, which Holmgren says is rare. In this example, if a manufacturer deviates from the standards, self-certification is not allowed. A notified body can accept deviations as long as the product is safe or safer than if it were built according to the standard, he says, adding that using a notified body can benefit marketing.