EU Certification and CE Marking

The term EU certification is actually a bit misleading, since there is no general certification that is needed to introduce products to the EU market. Instead, manufacturers or distributors follow a conformity assessment procedure for each product, which involves various EU directives and regulations. Placing a CE marking on the product is often part of this procedure to show that it complies with all relevant directives and regulations. Depending on the product category and the directives and regulations that are relevant for this category, an EU type examination can be part of the conformity assessment procedure, after which an EU Notified Body issues an EU type examination certificate for the product.

Which products need a CE marking? Which ones need an EU type examination certificate?

Various EU directives and regulations determine which products need a CE marking for EU market access, and which ones need an EU type examination certificate. The CE marking is needed for a large number of product categories, but a type examination is only required for a smaller subset of these.

A large number of electrical devices, for example, falls either under the Low Voltage Directive (2014/35/EU) or the EMC Directive (2014/30/EU) or both, whereas devices with radio components usually fall under the Radio Equipment Directive (2014/53/EU) as well. Virtually all products covered by one of these directives will need a CE marking as part of the conformity assessment procedure. Which ones require an EU type examination certificate is laid out in the various directives and regulations.

What do I need for CE marking?

The conformity assessment procedure can vary from product to product, but generally these steps must be followed:

• The product needs to be classified. It must be determined what type of product it is and which directives or regulations are relevant for it. If it contains a radio module, for example, the Radio Equipment Directive (2014/53/EU) may be applicable.
• Based on the relevant directives and regulations, the relevant steps for the conformity assessment procedure must be identified. These may include an analysis of risks and essential health and safety requirements relevant for the product, as well as product testing according to relevant European standards.
• In many cases, e.g. for an EU type examination, a technical documentation must be prepared. Which elements this documentation includes will vary depending on the relevant directives and regulations. Usually technical drawings and manuals are part of it, for example.
• After conformity assessment has been completed, an EU Declaration of Conformity must be drawn up, which states the conformity with all relevant directives and regulations.
• The CE marking must be affixed to the product, together with other relevant markings required by the directives and regulations (e.g. four-digit number of a Notified Body, model name etc.)

What does testxchange offer?

testxchange supports OEMs, manufacturers, distributors, and retailers from anywhere in the world in their efforts for access of their products to the European Union (EU). As your reliable partner, we get all necessary testing and certification done, so your product can be legally marked with the necessary CE marking in a fast and cost-efficient way. In order to always fulfill the legal requirements, it is of vital interest to stay up-to-date with any changes in rules and regulations. testxchange can take care of this for you as well. Do you have more questions regarding what you need in order to prepare your product for EU market access? Just contact our experts for free to get clarity on the next steps!