Our country has signed the Customs Union agreement with the European Union which entered into force in 1996 and started to work for the inclusion of technical legal regulations in our legal system. In these studies, determined by the Decision of the Association Council to harmonize regulations and application conditions and rules by Turkey, the list of these regulations are based.

In this context, the 4703 framework law and the Law on the Preparation and Implementation of Technical Legislation on Products based on this law have been published and entered into force in 2002. In addition, the regulations introduced were as follows:

  • Implementing Regulation on the Attachment and Use of the CE Conformity Mark to the Product
  • Regulation on Market Surveillance and Inspection of Products
  • Regulation on Conformity Assessment Bodies and Notified Bodies
  • Between the European Union and Regulation on Notification of Technical Regulations and Standards in Turkey

It was then adopted by the European Union. New Approach Directives started to become legalized one after the other.

Manufacturer's products CE label the first thing they need to do is determine which directives their products fall under. It is not correct to engage in CE studies without knowing the purpose, scope, criteria and basic requirements of the relevant directive. At the same time, the standards for the product and the compliance with these standards should be determined in advance.

Then, the relevant risk analyzes should be carried out and whether the product carries low risk or high risk and CE marking The scope of this product should be known from the beginning.

As is known, in low-risk products, the product complies with the safety requirements of the directive, ie conformity assessment for high-risk products, this assessment should be carried out by the notified body.

For low-risk products, it is the manufacturer's authority to put the CE label on the product according to the results of the conformity assessment study. However, for high-risk products, such as medical devices, testing and inspection of products must be carried out by notified bodies. These organizations are designated by the Council of Europe and published in the Official Journal of the European Union.

The manufacturer only decides the conformity assessment according to the results of the certificate issued by the notified body and places the CE mark on the product.

However, in both cases, the manufacturer may technical file must prepare. Another requirement for the manufacturer is to prepare a declaration of conformity stating that the product is manufactured in accordance with the relevant directive criteria and to include this declaration in the technical file.

After these steps are completed, CE label can be put on the product.

The TÜRCERT certification body primarily focuses on certification studies. However, in addition to these studies, it also offers technical services such as various test and inspection studies. Therefore, if you need more information about what the CE label means and what you need to know about the product CE Certificate, do not hesitate to contact the managers and employees of the TÜRCERT certification body.