CE Mark and European Union Directives

 

PTI can determine which directives and standards are required for your product to ship to Europe.

What is the CE Mark?

The European Union (EU) is a conglomeration of 27 different countries in Europe that have all agreed on certain trade laws, among other things. One of the agreements made is that the CE Mark is required on all products shipped throughout the European Union. The CE mark signifies that the product has followed “directives”, an assortment of requirements depending on the features and intended use of the product. The CE Mark is the equivalent of an NRTL mark here in the United States. The difference, for most products, is that there is no approval agency; instead, the CE Mark works under a method of “self declaration.”

Understanding CE Mark Directives

A manufacturer is still required to perform the testing and keep the results in a technical construction file. This file is not submitted to an agency unless it is requested for review by a representative of the EU. Generally, a “declaration of conformity” to demonstrate compliance with the CE mark rules is shipped through customs into the EU along with your product. The declaration of conformity is a 1-page summary of the directives and laws you have used to declare conformity of your product. The CE Mark looks like this:

What can PTI do to help you obtain a CE Mark for your product?

We can determine which directives and standards are required for your product to ship to Europe. We can perform testing in accordance with the Low Voltage Directive (specific for product safety), Medical Devices Directive, Machinery Directive and other directives, including the EMC Directive, with our EMC Capabilities. We also have consulting services to help you maintain a technical construction file, and we can even help you draft your declaration of conformity. Here are a few examples of Low Voltage Directive testing which are similar, and in some cases, identical to the testing required for NRTL compliance:

Standard Description
EN 60950 IT Equipment
EN 61010 Laboratory, Medical, and Control Equipment
*EN 60825 Laser Products
EN XXXX Although we specialize in the above standards,
there are many more we can evaluate product to,
just ask.

* Laser Products:
Any product containing a laser for sale in the European Union should show compliance with EN 60825. This standard ensures the safety of a laser product through the measurement of accessible laser radiation, laser product classification, labels and documentation. PTI can evaluate your product to EN 60825 and assist you with the required documentation for compliance with this standard.

Why Choose PTI?

We help our customers be proactive by getting involved early in the design phase, designing in reliability and compliance. The result is bringing products to market faster with less cost, and better service.  Learn More >

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