CE Marking Procedure

CE marking product requirements and certification procedures are laid down in European Directives. There are currently approximately 25 CE marking Directives for different product groups (e.g. machinery, toys, medical devices) or product aspects (e.g. electromagnetic compatibility). Please note also that more than one Directive can apply to a single product. For that reason, it is important to first identify which CE marking Directives apply to a product.

For each directive you will need to do a risk analysis. Such risk analysis is related to the risk to do not fulfill the essential requirements ( check the blue book guide on such matter).

The best and simpler way to do cover the risk is the use of Harmonized standards ( see next step).

For each directive, check in the specific official journal of european union the applicable Harmonized standards.

Harmonized standards are standards, which are accepted by the European legislators as providing proof of compliance with the Directive(s) once the requirements of these essential requirements are met. Therefore applying harmonized standards is the easiest way of proving compliance with the Directives requirements.

This step entails a product assessment against the applicable requirements from the Directives and standards identified during step 1 ..3 . Conformity assessment may involve product testing, visual inspection, risk analysis, as well as a review of the product label and instructions.

In some cases, but not in all cases, it is mandatory to have the conformity assessment performed/verified by a third party. This third party is referred to as “Notified Body”.

Every CE Directive requires the manufacturer or importer to fill in and keep available for inspection a so-called Technical Dossier. The purpose of the Technical Dossier is to provide documented evidence of the product’s compliance. Therefore the Technical Dossier  should contain at least all information about the product which allow the authorities to:

• identify the product;
• determine the configuration of the product that was approved;
• determine which standards were applied;
• determine which directives were applied;
• determine how the product meets the requirements of the relevant directives and standards;
• identify the manufacturer and manufacturing process;
• determine how the manufacturer ensures consistent quality of production and continuous product compliance;

Which documentation exactly needs to be provided in the Technical File is defined  in the text of the each Directive.

The symbol CE will need to be applied to the product according to the rules specified in each directive.

In almost all cases the affixing of the CE marking is obligatory. Please note also that some CE Directives do not require CE symbol.