Since 1985, when the New Approach program was introduced, any product sold to the European Union and the European Economic Area countries must bear the CE mark. The CE marking means that the products marked with this mark comply with the legal requirements of the European Union. This means that these products meet the requirements of the European Union directives and harmonized standards.
In the CE marking system, some products only allow the manufacturer to test their products and carry out factory production quality checks to meet compliance requirements. In this case, the decision to put the CE mark on the products is entirely at their discretion. However, for some products, the manufacturer will need a notified body's testing and approvals. However, even if this decision is based on the approval of a notified body, the products must undergo a series of tests for the declaration of conformity in each case.
Conformity tests are conducted to determine that the products on which the CE marking is placed meet all requirements within the scope of the relevant New Approach directives and harmonized standards.
The main objective of the CE marking is to assist the free trade of products within the European Union and to minimize the impact of physical borders between countries. At the same time, the CE marking ensures product safety throughout the European Union and promotes compliance with legal criteria for the environment.
Today, there are over 20 directives, which include the CE marking requirements and are published under the New Approach Directives. Each of the Member States has incorporated these requirements into their national law. In our country, these directives have been adapted to our domestic law within the scope of harmonization studies with the European Union. Harmonized standards were also translated into Turkish by the Turkish Standards Institute (TSE).
The CE marking application typically includes the following requirements:
Conducting a risk analysis for products: This process is used to determine the existence of any risks associated with products and the level of risks to people, animals, goods and the environment. Producers must also plan their solutions to reduce these risks.
Preparing a user manual in the language of consumers: This manual should describe the intended use of the product and any prohibitions and warnings. It should also include simple inspection and maintenance instructions.
Preparation and signing of the declaration of conformity to the European Union: In this declaration the manufacturer must state which directives or directives the product meets the harmonized standards.
Preparation of technical dossier: Design data, drawings, calculations and test reports together with the documents listed above should be collected in a technical dossier. The technical dossier that must be kept for ten years is proof that the product meets the requirements of the relevant directives.
The biggest challenge in this application is that the manufacturers determine which CE marking directives or directives apply. There is no definite product list that manufacturers can rely on. In this respect, it is considered beneficial for the manufacturers to get support from the competent and experienced organizations in CE marking in order to accelerate the processes and not to mislead them. This is also important in terms of conducting conformity tests in advanced laboratories and providing detailed and reliable reports in the technical file. Even in cases where CE marking is at its discretion, such laboratory tests are important to avoid future problems.
Our company also provides conformity test services within the scope of certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.
The conformity test services provided within the scope of certification services are only one of the services provided by our organization in this respect. Many other certification services are also available.