Before the European Union published the New Approach Directives in 1985, there was a Classic Approach and specific standards were set for each product. However, especially due to the rapid change in technolgies, when the union began to make standard updates and had difficulty in preparing new standards, it started to search for a solution by grouping the products. New Approach Directives it has emerged in this way. This new program also introduced new regulations in testing and inspection and certification.

CE Marking Methodis a method that has emerged at this stage and has been implemented since 1985. It is accepted that the products bearing the CE label comply with the criteria laid down by the European Union in terms of human and animal health and environmental conditions.

The CE marking of the products is followed by different routes depending on the product groups and the risks they carry. Now let's take a look at how product certification work is done.

  • Preparation of the technical file

Manufacturer companies, CE label For products to be put in, they must prepare a technical file containing information and documents that will show the product characteristics and conformity with the basic requirements described in the relevant directive. Although this technical file is of low risk, it will be prepared by the manufacturer.

  • Manufacturer's declaration of conformity

The manufacturer prepares a declaration of conformity, stating that it fulfills all the requirements of the criteria and standards of the directive on the product. This declaration of conformity, which is declared by the manufacturer to produce according to all conditions, is put into the prepared technical file.

  • Conformity assessment work

If the product is a low-risk product, the manufacturer will conduct the conformity assessment. He will carry out all the analyzes related to the product himself and will, if necessary, carry out the tests and controls with a test and inspection body and decide for himself whether the product meets the requirements of the relevant directives. However, if the product enters the high risk group, the manufacturer must apply to the notified body.

  • Applying to the notified body

Conformity assessment for high risk products is carried out by notified bodies within or outside of the country. The notified body does not decide for the CE marking, only evaluates the conformity in terms of the directive criteria and eventually submits a report and delivers it to the manufacturer.

  • CE labeling

The manufacturer places a CE marking on the product on the basis of its own conformity assessment work on low risk products and on the basis of the report issued by the notified body in high risk products. If the product does not meet the expected criteria, the manufacturer must not place a CE marking on the product in any way. Otherwise, it may be subject to criminal sanctions.

TÜRCERT certification body is primarily focused on certification activities. In addition to these studies, it also provides technical services such as various test and inspection works. Therefore, if you need more information about what the CE label means and what needs to be done for product certification, please do not hesitate to contact the expert managers and employees of TÜRCERT certification body.