CE Marking

The CE symbol indicates that the product conforms to the essential safety requirements laid down in one or more EU directives applicable to the product itself. It must be affixed to the product before it is placed on the market, except in cases where the specific directives provide otherwise. It should be affixed on the product and/or packaging and/or instructions for use.

The CE marking is mandatory for all products that fall into one of the Community Directives relating to the CE marking in the European Union member countries.

Applicable EC Directives will change depending on the type of product. For each directive is available the list of harmonized standards to which the product should be subject, so it is not possible to affix the CE mark without first carrying out all the tests set out by the legislation.

The CE marking must ALWAYS be affixed by the manufacturer, even if he lives outside the European Union.

The manufacturer (or the importer, in the case of goods produced outside the EU) must:

1. draw up a “CE declaration of conformity” which indicates the directive/s applied and standards used;
2. prepare and keep a “technical construction file” descriptive of the technical characteristics of the product and tests carried out proving the safety of the product itself.

Warning! Declare compliance with harmonized standards means having successfully followed all the tests required by them. This documentation must be available on request of the competent authorities to monitor the market.

The steps required to affix the CE mark in the correct way are generally:

1. Check the applicable EC directives
2. Check the applicable technical standards
3. Perform the tests required by the technical standards
4. Affix the CE mark on product, packaging, user manual
5. Assemble the technical construction file
6. Involve, if necessary, the Notified Body
7. Draw up a declaration of conformity