The CE marking is used by the European Union under the New Approach Policy issued in 1985 within the framework of technical legislation compliance. The CE mark indicates that products covered by the New Approach Directives meet the requirements of these directives. In addition, products bearing the CE mark prove that the product has undergone the necessary conformity assessment activities by the manufacturer or its authorized representative or, if required by the directive, the third party conformity assessment body.
Briefly, the CE mark indicates that the products comply with the relevant technical regulations and that if the products are used for their intended purpose, they will not harm people's life and property, plant and animal existence and the environment.
The relevant directives may require that some or all of the basic requirements for the use of the CE marking be met. Apart from safety, some directives may also be related to different dimensions, such as electromagnetic compatibility or energy efficiency.
What is the Status Related to CE Mark Application in Turkey?
Pursuant to the Decision of the Association Council No. 1 / 95, which establishes the customs union between the European Union and our country, our legal arrangements should be harmonized with the European Union in order to ensure free movement of goods and to remove technical barriers to trade. These studies are carried out under the coordination of the Ministry of Economy. Some of the adaptation works carried out by the related public institutions have been completed and some of them are still in progress. When the European Union regulations are updated, our country is also making updates. CE marking on the products is among these studies.
In this context, the Law on the Preparation and Implementation of Technical Legislation on Products was issued by the Ministry of Economy in 2001. Later on, based on this law, the following regulations were issued in the same year:
- Regulation on Conformity Assessment Bodies and Notified Bodies
- Implementing Regulation on the Attachment and Use of the CE Conformity Mark to the Product
- Regulation on Market Surveillance and Inspection of Products
- Between the European Union and Regulation on Notification of Technical Regulations and Standards in Turkey
However, with these regulations, the obligation of using CE marking on the products did not immediately begin. In addition to the entry into force of the harmonized regulations, the standards referred to by these directives had to be published. This is fulfilled by the Turkish Standards Institute. Therefore, there is no single application date for CE marking in our country. The application of the CE marking begins as the relevant product legislation enters into force.
Why Using CE Marking is Important
Since the CE mark is a mark placed on the products covered by the New Approach Directives, the products that will be offered to the market in European Union countries and in our country must bear this mark. This means that the CE marking is like a passport for the free circulation of these products. It is not possible to export the products which do not carry this mark to the countries of the European Union even though it should have CE marking. The same situation is valid for the products that will be offered to the domestic market in our country.
The CE marking is used on products included in the New Approach Directives. How to place this mark on the product is described in the product directives.
The manufacturers or their authorized representatives are responsible for placing the CE mark on the products and placing them on the market. If the manufacturer or the authorized representative of the manufacturer is not established in our country or in the countries of the European Union, the importer of the product must confirm that it carries the CE mark on the product. In other words, the importer companies must guarantee that the imported products comply with the norms of the European Union.
There are different ways for manufacturers to put CE marking on the product:
- Generally, for some product groups with low risk or easily understood risk sizes, for example for some machines, the manufacturer's declaration of conformity is sufficient to ensure that it complies with the essential requirements of the directive, and the manufacturer may affix the CE marking on the product itself. The manufacturer may determine the conformity in question by means of the test facilities it owns or verify the conformity using the facilities of any other organization.
- Some other products, such as some medical devices and machines, need to be verified by notified bodies. According to the report to be submitted by the notified body as a result of the inspection, manufacturers may affix the CE mark on the product.
What Does Notified Body Mean
Under the New Approach Directives, a number of product groups have been considered high-risk. The declaration of conformity of the manufacturer or its representative is not sufficient for such high risk products. Prior to the release of these products, a third party and an expert in its field, as well as an organization published in the Official Journal of the European Union, must be assessed for conformity.
Organizations that test and inspect such high-risk products and certify compliance are selected by the member states of the European Union with sufficient infrastructure. These organizations are called notified bodies. These notified bodies designated by the Member States shall be notified to the Council of Europe. The Council of Europe also publishes notified bodies in the Official Journal of the European Union for the purpose of announcing to other member states. The names and addresses of notified bodies operating in this manner are also published on the NANDO website. Notified bodies must therefore be technically competent.
Nando is the European Union's New Approach Notified Bodies Organization Information System (http://ec.europa.eu/enterprise/newapproach/nando/).
Some rights have been granted to our country within the scope of harmonization studies with European Union legal regulations. Within this framework, Turkey has the right to appoint a notified body within the scope of the legislation harmonized by our country with the Decision of Association Council No. 2006. In this way, manufacturers and exporters in our country who produce high risk products and want to put CE mark on their products, can get certification services from national institutions.
The notifications of candidate notified bodies that are deemed appropriate by the Ministry of Economy are forwarded to the European Commission via the NANDO Information System of the European Union. NANDO system lists the organizations that are currently working in our country and the areas in which these organizations operate.
Which New Approach Directives Require CE Marking
With the New Approach Directives, standards for health and safety have been introduced for many products. The products are proved to be in conformity with the basic requirements of the relevant directives and to undergo the necessary operations with the CE marking. New Approach Directives published in our country which require CE marking in parallel with the harmonization studies are as follows:
- Regulation on Gas Burning Devices
- Implementing Regulation on Wired Transport Installation Designed to Carry Human
- Construction Materials Regulation
- Electromagnetic Compatibility Regulation
- Implementing Regulation on Equipment and Protective Systems Used in a Potentially Explosive Environment
- Implementing Regulation on the Supply and Inspection of Explosives for Civil Use
- Lift Regulation
- LVD Low Voltage Regulation
- Machinery Safety Regulation
- Implementing Regulation on Measuring Instruments
- Medical Devices Regulation
- Implementing Regulation on the Efficiency Requirements of Liquid and Gas Fired New Hot Water Boilers
- Implementing Regulation on Non-Automatic Weighing Instruments
- Personal Protective Equipment Regulation
- Regulation on Pressure Equipment
- Implementing Regulation on Wireless and Telecommunication Terminal Equipment
- Recreational Craft Regulation
- Implementing Regulation on Simple Pressure Vessels
- Regulation on Toys
In the product sales to be made from many countries of the world to the European Union countries, the manufacturers have to put the CE mark on the products in the same way that the European Union countries apply among themselves. If it is desired to export to the European Union market, they must operate in accordance with the principles of New Approach Directives during the design and production stages of the products and carry out the necessary conformity assessment processes in accordance with these directives.
Modular Structure of CE Marking System
CE Marking System has a modular structure that takes into consideration the conformity assessment methods and the characteristics of the products and the risks they carry. At least one of the modules must be applied during the design and production stages of the products to determine that the relevant directive principles are complied with.
These modules, named A to H, contain certain risk groups and classify products according to their degree of risk.
In fact,
· Testing and certification studies for conformity assessment of low risk products are carried out directly by the manufacturer.
· The testing and certification studies required for conformity assessment of high-risk products are carried out by bodies approved by the European Union.
If you look at the features of these modules briefly:
- Module A: Internal Production Control
In this module which includes the design and production stages, the manufacturer prepares a technical document explaining the design, production and usage conditions of the product and declares that the product complies with the relevant directives. There is no need to go to the notified body.
- Module B: Type Examination
This module is only related to the design stage of the product. It is usually used in conjunction with a declaration of conformity. CE marking is not required.
- Module C: Declaration of Conformity to Type
This module only relates to the production stage of the product. Alone is not enough. This is the next step after Module B. In order to prove that the product complies with the relevant directive requirements, the manufacturer makes a declaration of conformity and affixes the CE mark to the product.
- Module D: Production Quality Assurance
This module is also related to the production phase and follows Module B. It involves testing and approving the production process by a notified body. The process is similar to the ISO 9000 standard. It is a quality assurance system related to the production process.
- Module E: Product Quality Assurance
This module is also related to the production phase and follows Module B. This includes testing and validating the product by a notified body. The process is similar to the ISO 9000 standard. It is a quality assurance system related to the production process.
- Module F: Product Verification
This module is also related to the production stage and is used in conjunction with Module B. If a notified body checks the conformity of the product to the technical documentation or the specifications in the type examination and gives a certificate of conformity, the manufacturer may affix the CE mark to the product.
- Module G: Unit Verification
This module covers the design and production stages of the product and if the notified body gives a certificate of conformity that the product complies with the relevant directives, the manufacturer may place the CE mark on the product.
- Module H: Full Quality Assurance
This module covers the design and production stages of the product and if the notified body determines that the product complies with the relevant directives and finds that the quality management system has been implemented, it will issue a certificate of conformity. The manufacturer can then put the CE mark on the product.
Benefits of CE Marking System
The companies that attach the CE mark on their products have much gains. For example,
- These products have free circulation and marketing opportunities in European Union countries.
- The reliability of these products is proven in international markets outside the European Union countries.
- The CE mark indicates that the products comply with the regulations of the European Union.
- CE marking is not a quality certificate or warranty certificate. Nevertheless, it is an expression of the quality of the products.
- Products bearing the CE marking cannot be rejected with legal justification for the directives.
our organization TÜRCERT Technical Control and Certification Inc.The CE Mark European Conformity Certificate is ready to assist with any doubts about certification work.