The CE marking glossary contains frequently used terms and phrases related to the CE marking process. Do you know what a harmonized standard, a European directive, and a Declaration of Conformity is? If your answer is a no, then continue reading below.
Legal directives that are set by the European Commission. These state requirements for all member states on what to include in their own national laws. Not all EU directives are directives in regards to CE marking. CE Check has included some non-CE marking directives in our service since some are essential to selling within the EU, regardless if they’re a part of CE marking or not.
When a standard is “harmonized” it means that the European Commission has concluded that the standard covers the requirements in a specific directive. The idea is that, by using a harmonized standard, you don’t need to worry about passing the requirements in the directive as this is automatically done when passing the requirements in the standard. This is called “presumption of conformity” and it is the easiest way to show compliance with a CE directive.
This is the technical documentation which demonstrates how the requirements of the directives have been met. The documentation contains information such as designs, test results, risk analyses, depending on the directives that need to be met.
Declaration Of Conformity
This is a document that states that you are CE marked. It contains information such as; product details, directives met, standards used, test results etc. This document is not valid without the technical documentation.
Some directives require a notified body, this is a specially appointed testing company which have been approved to confirm whether a product meets the requirements in the CE directives. In most cases, notified bodies are not needed but e.g. medical devices tend to need one.
Testing & testing institutes
Most products need to go through testing to prove that they adhere to the directives as they state. Depending on the product, the testing may be very limited or extremely extensive. For example, imagine the difference of testing an HDMI adapter and a pacemaker.
Testing institutes are companies providing testing services to help you prove that you conform to the directives. Some of these may also be notified bodies.