CE - European Union

One of the most critical elements of marketing products in the European Union (EU) is proper use of “CE Marking”.

The CE conformity marking has to be affixed visibly, legibly and indelibly. The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5mm.

The CE marking should be affixed by the manufacturer or his authorized representative established within the European Community to one of the followings:

• the apparatus itself;
• the packaging;
• the instruction for use;
• the guarantee certificate.

What is involved to reach the EU market? 

For most products, a single set of harmonized regulations, known as Directives, has replaced individual national rules. Each Directive requires compliance to specific regulations appropriate to the products within its scope. If your product needs to meet the requirements of all applicable Directive(s), you may want the expertise of an independent third-party testing house before you apply the CE mark to your product.

Steps to Compliance 

Although you are responsible to submit the completed paperwork for CE Marking, Intertek's independent testing and certification expertise can assist you during the compliance process.

Intertek is experienced to help with all the key elements of European Union market access:

Declaration of Conformity (DOC) 

When you submit this documentation prior to importing and distributing products into the EU, you are asserting that your products have met the requirements of the relevant EU Directive(s).

Technical File (TF) 

This documentation supports your Declaration of Conformity. It must contain drawings, test reports and the explanation of how your product is in compliance. A Technical Construction File (TCF), is required for the EMC Directive. Supporting documents in the TF can help limit liability when prepared by an independent, third-party testing and certification laboratory, such as Intertek.

Each Directive specifies where this support documentation must be kept, and for how long, in case you are called upon to present it to authorities.

Notified Body 

You may deal with a Directive that requires you to work with a Notified Body. A Notified Body is an independent laboratory or organization that has been accredited by national authorities and notified to the EU Commission (Intertek has three Notified Bodies).

CE Marking 

The CE mark on your product indicates that the requirements of all necessary Directives have been met prior to it entering the EU.

Follow-up Services 

Under certain sections of Directives (e.g. the Medical Devices Directive), you may need follow-up services by a Notified Body. This service ensures the product is manufactured the same way as indicated in the test reports.