Usage of CE Mark and Technical File
The CE conformity mark is a sign that the manufacturer has fulfilled all obligations arising from the relevant legal regulations and technical principles and that the product has gone through all necessary conformity assessment procedures. Conformity assessment procedures are related to the testing, inspection and certification of the product in accordance with the required technical principles.
The basic requirements of the CE marking application are to protect the health and safety of people, products and products, which bear this mark, not to harm the lives of animals and plants, to protect natural environment conditions and to protect the rights of consumers. The CE mark indicates that the minimum safety requirements for products are met for all these requirements.
The manufacturer must prepare a technical dossier in accordance with the Regulation on the Attachment and Use of the CE Mark of Conformity, which regulates the principles for affixing the CE marking to the products. This technical dossier shall contain reports and documents indicating that the product to which the CE marking is to be manufactured is produced in accordance with the requirements of the relevant legal regulations and technical principles, and information concerning the design and production of the product.
The aforementioned regulation contains modules that explain how to carry out conformity assessment procedures. These modules show which conformity assessment process will be subject to the risks of the product in accordance with the relevant regulations. The module or modules to be affixed to the products for the CE conformity marking are specified in the relevant technical regulation.
CE Conformity Report
One of the important points in CE marking system is the report to be put into the technical file to be prepared. This report shows that the company manufactures in accordance with the relevant legal regulations and that its products comply with the requirements of the relevant technical regulations.
Depending on the degree of risk the product carries, the report may be directly issued by the entity or, in certain risky situations, may be required by the notified body.
In general, for a number of product groups, which are relatively easy to decide whether they are high-risk or risky during use by the consumer, the manufacturer may decide that these products comply with the European Union directives and applicable regulations. These are considered low risk products. For example, some simple machines fall into this group. The manufacturer may make this decision by using its own testing facilities or by taking advantage of the facilities of any organization as and when necessary. In this case, he must draw up a conformity report based on the test results or directly on his own decision and put it in the technical dossier.
However, with some complex machines or some medical devices, this is not so simple. The risks of such machinery and equipment are considered to be high level and must be tested and inspected by the notified body. After the studies to be carried out by the notified body, if the products, tests and examinations to be marked with CE marking are successfully provided, the conformity report is issued by the notified body. Businesses must keep this compliance report in the technical file.
Enterprises cannot put the CE mark on the products without the conformity report issued either by themselves or by the notified body.
Our country made a customs union agreement with the European Union in 1995 and the free movement of the products produced in our country was ensured in the European Union countries. Following this agreement, European Union harmonization efforts were initiated to eliminate technical barriers to trade. In the year 1999, our country has gained the status of being a candidate for full membership of the European Union. Within this framework, our relations with the European Union has gained a new dimension after the Customs Union. This CE marking system is a result of this.
The legal regulations for the use of CE marking during the harmonization studies are as follows:
- Law on the Preparation and Implementation of Technical Legislation on Products (Published in 2001)
- Implementing Regulation on Conformity Assessment Bodies and Notified Bodies (Published in 2002)
- Implementing Regulation on the Attachment and Use of the CE Mark of Conformity (Published in 2002)
- Regulation on Market Surveillance of Products (Published in 2002)
- Regulation on Notification between the European Union's Technical Regulations and Standards of Turkey (published in 2002)
Immediately after the said legal regulations were made, technical regulations were started to be prepared, which would necessitate the obligation of CE marking on the products.
The technical regulations stipulating the CE marking on the products produced in our country and which will be offered to the domestic market are made by the Turkish Standards Institute. Because the harmonization of the relevant technical regulations is practically applicable, not only the harmonization of the legal regulations is required, but the standards to which these regulations refer. In other words, harmonized national standards should be prepared.
Therefore, the application of CE marking in our country has not started on a single date. As the relevant harmonized standards are published, the CE marking of this product has also started.
CE marking has become a necessity for the development of foreign trade of our country and the easy presentation of the products to the European Union market. At the same time, it is important that the products bear CE mark in order to gain competitive advantage in the domestic market and to offer better quality and reliable products to consumers.
The CE marking application is mainly for products that fall under the new approach directives prepared under the New Approach Policy adopted by the European Union in 1985.
The manufacturer has a great responsibility to put the CE mark on the products. The conformity report to be included in the technical dossier as described above is very important at this point. If an entity acknowledges that its products are at low risk and draws up the conformity report on its own and affixes the CE marking to the product, it means that it is responsible for both the future of the enterprise and the respectability of our country in international markets.
