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Step 1 - Determine applicable regulations & standards

Classification Rationale: Determine applicable regulations

Probably the most important step in the CE marking certification process is to determine which CE marking directives apply to your product. Only after you know which directive or directives apply, you can determine which requirements the product must fulfill and how the compliance must be assessed.

You may want to give this step some special attention because if the wrong directives are selected and applied, all your CE marking efforts will be in vain. And your products could even be prohibited from sale in Europe.

Finding out which CE marking directive applies to your product, can be very complex and time-consuming. There are currently more than 25 CE marking directives, and more than one CE marking directive can apply to a single product.

Have you been looking for a database or list that tells you which directives and standards apply to a product? You can stop searching. Such a list or database does not exist.

The field of application of European CE marking directives is simply not determined by a list of products. Of course, that would have made it so much easier. But it would also mean that the CE directives would be rigid and not flexible enough to include brand-new technologies. And as you know, the state of the art in technology is changing constantly. So, instead of providing lists of products to which a directive applies, the European legislator took a different approach: to give a definition or a description of product features that determine if a product falls within the field of application of a directive.

This makes the process of finding the applicable directives complicated and rather frustrating if you are not a specialist. Basically, because you need to check some 25+ directives before you can draw conclusions.