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WHAT IS CE CERTIFICATE? HOW TO OBTAIN IT?

What is CE Marking?

The CE mark (Conformité Européenne) is an official mark indicating that a product complies with the health, safety and environmental protection standards of the European Union. This document ensures that the product can circulate freely in EU countries and also shows that it meets all legal requirements. The CE mark basically indicates that the products meet three main standards: health, safety and environmental protection. This allows manufacturers to sell their products on the European Union market without any restrictions.

The Importance of CE Certificate in Terms of Product Safety

The CE certificate is an important document that documents compliance with the health, safety and environmental protection standards determined by the European Union in terms of consumer safety. Consumers can understand that the product complies with EU standards and can be used safely by seeing the CE mark on the product. This mark shows that the product has undergone a comprehensive risk analysis and has been found suitable. CE marking is of vital importance especially in products that may directly affect human health such as electronic products, medical devices, toys and construction materials.

Legal Basis of CE Certificate

The legal basis of CE certificate is regulated by the New Approach Directives of the European Union. These directives aim to maintain high safety standards while ensuring the free movement of products. All products manufactured or imported within the scope of the directives must meet health, safety and environmental protection standards. By adding the CE marking to the product, the manufacturer or importer company declares that these requirements are fully met. This declaration also shows that the manufacturer assumes legal responsibility for the product and secures consumer rights in case of possible problems.

CE certificate is valid in Türkiye within the framework of technical legislation compatible with the EU and is considered a mandatory legal requirement.

How to Get a CE Certificate?

To get a CE certificate, manufacturers must follow certain procedures by making their products compliant with European Union standards. Although the certification process for each product category varies, the basic stages are similar.

CE Certificate Application Process

The CE certificate application process begins with determining which regulations the product falls under. A specific EU directive applies to each product and the application process is shaped according to this directive. Once the regulations are determined, the manufacturer or importer company starts the process for the necessary tests and documents.

• Documents Required for CE Certificate Application

The following documents must be prepared for CE certificate application::

• Photocopy of trade registry gazette
• Signature circular copy
• Tax plate copy
• Chamber of Commerce registration document copy
• SSK service statement copy
• Material certificates
• Product user manuals
• Technical drawings of the product

These documents are mandatory documents required for the application to be considered valid and fully evaluated.

• Filling Out the Application Form

A special form must be filled out for the CE certificate application. The form includes the following information::

• Technical specifications and details of the product
• Current contact information of the manufacturer or importer company
• EU directives to which the product is subject

Filling out the form completely and accurately will significantly speed up the application process.

CE Certificate Obtaining Stages

The CE certificate acquisition process consists of five basic stages: initial assessment, testing processes, preparation of the declaration of conformity, affixing of the CE mark to the product and follow-up inspections. At the end of this process, the conformity of the product to European Union standards is confirmed.

• Product Testing and Inspection Processes

Products must undergo comprehensive tests in order to apply for a CE certificate. These tests verify the safety of the product and its compliance with the standards. Tests applied specifically to each product category include electrical safety tests, mechanical durability tests and chemical analyses. These tests conducted by accredited organizations guarantee the validity of the CE mark.

• Technical File Preparation

The technical file is a critical stage of the CE certificate application. This file includes all technical specifications of the product, design and production details, test results and information on the materials used. Manufacturers are obliged to keep this file as long as the product is on the market, because the file is proof of the product's compliance with the relevant directives.

• Creating a Declaration of Conformity

The product declaration of conformity is an official document prepared by the manufacturer. This document guarantees that the product complies with the relevant regulations and ensures that it can be legally sold on the European Union market. The declaration provides the legal basis for the use of the CE marking by clearly stating the standards and regulations that the product meets.

Authorized Organizations

Authorized organizations are independent organizations that provide inspection, testing and evaluation services during the CE certification process. Manufacturers must definitely receive support from these organizations, especially for high-risk products. These organizations evaluate the conformity of products to EU directives and decide whether or not the CE mark will be given.

• Authorized Institutions Issuing CE Certificates

The authorized institutions that issue CE Certificates are organizations accredited by the European Union. In Türkiye, various institutions, primarily TSE (Turkish Standards Institute), provide CE certification services and perform conformity assessment of products. These organizations, with their expert staff, examine the products in detail and issue CE certificates.

• Advantages of Working with Accredited Organizations

Working with authorized organizations ensures that the CE certification process is completed reliably and quickly. These organizations impartially evaluate the conformity of products to current EU standards and facilitate access to the European market. The experience and expertise of these organizations provide significant advantages to manufacturers, especially in complex and high-risk products.

It is important to remember that obtaining a CE certificate is both a legal obligation and a process that provides a competitive advantage in the international market. Correct guidance and complete document preparation are critical for successful certification.

For Which Products is CE Certificate Required?

CE Certificate is a legal requirement for certain products to be sold in the EU market. This certificate shows that the product complies with the safety, health and environmental protection standards determined by the EU. CE marking is a quality indicator that ensures the free movement of products within the European Economic Area (EEA). Therefore, it is mandatory for all products planned to be sold in the EU market and falling into the relevant product categories to have CE certificate.

Product Categories Requiring CE Certificate

CE certificate requirement is regulated within the scope of "New Approach Directives" that determine the health, safety and environmental protection standards of the EU. These directives aim to ensure product safety, especially for high-risk product groups. The basic product categories that require CE certificate are listed below:

• Electronic Products

Compliance with EU directives such as electromagnetic compatibility (EMC) and low voltage is a must for electronic products. Phones, computers, televisions and home appliances are considered within this scope and must comply with the electronic device directives.

• Medical Devices

Since they directly affect human health, CE certification is mandatory for all medical devices. Surgical equipment, diagnostic devices, implants and other medical devices must carry the CE mark indicating that they comply with the medical device directive.

• Toys

CE marking is mandatory for toys for children's health and safety. All toys must meet physical and chemical safety standards within the scope of the European Union Toy Safety Directive. This directive aims to prevent the use of harmful chemicals and the risk of asphyxiation.

• Construction Materials

Construction materials such as cement, glass and insulation materials must carry the CE mark. This certification documents the materials’ compliance with the criteria of durability, fire resistance and environmental impact.

Is it mandatory to obtain a CE certificate?

The CE certificate is a mandatory certificate for products within the scope of certain regulations. This certificate aims to protect the health and safety of consumers, while also ensuring the free movement of products throughout the European Union. Products evaluated within the scope of the relevant regulations cannot enter the European market without the CE mark. For this reason, obtaining a CE certificate is mandatory for manufacturers who want to sell their products within the borders of the European Union.

• Obligations in the European Union Internal Market

In the European Union internal market, the CE mark is necessary for the free movement of products and for consumers to use them safely. The CE mark indicates that the products comply with the health, safety and environmental standards determined by the European Union. Businesses within the borders of the European Union cannot import or sell products that do not comply with these standards.

• Consequences of Selling Products Without a CE Mark

Products without a CE mark are not allowed to be sold in the European Union market. Products offered for sale without a CE mark pose a great legal risk, while sellers may face serious sanctions. Authorized inspection bodies have the authority to withdraw and destroy products without a CE mark. In addition, businesses selling products without a CE mark may be subject to fines and legal sanctions. This situation can damage brand reputation and lead to a loss of confidence in the market.

Technical Standards Required for CE Certificate

Products that will apply for CE certificate must comply with the technical standards determined by the European Union. These standards are defined in the relevant directives and aim to guarantee the safety, health and environmental compatibility of the products. Different technical standards are determined for each product category.

CE Marking and Technical Legislation

A comprehensive assessment must be made for the compliance of products that want to receive CE Certificate with certain regulations. Technical legislation requirements for each product category are specified in detail in the relevant regulations and standards.

• Technical Standards Applied to Products

Technical standards determine the safety and performance criteria of products from production to end of life. These standards focus on different areas according to product categories:

• Safety and Health Standards: Includes physical, electrical and chemical protection measures to ensure user safety. These standards cover a wide range of products from electronic devices to medical equipment, toys to building materials.
• Environmental Protection Standards: These are rules determined to keep the environmental impacts of products at a minimum level. They especially cover regulations aimed at preventing the release of harmful substances in chemical products.
• Durability and Performance Standards: They determine the physical and mechanical durability criteria required for products to maintain their performance throughout their expected lifespan.
• Electromagnetic Compatibility (EMC) Standards: These are technical criteria that ensure that electronic devices operate without adversely affecting each other. These standards ensure that devices are not affected by electromagnetic interference and do not cause interference to other devices.

The implementation of these standards is monitored by strict quality control mechanisms during the production process. Manufacturers prepare detailed test reports and technical documentation to prove that their products comply with the standards.

• Conformity Assessment

Conformity assessment is a comprehensive examination process that verifies the compliance of the product with the specified technical standards and regulations. The manufacturer or importer must have this assessment done to prove that their product complies with EU standards. The process includes laboratory tests, technical examinations and certification stages. As a result of the successful assessment, a declaration of conformity is issued and the product gains the right to use the CE marking.

The assessment process varies according to the risk category of the product. While the manufacturer's self-assessment may be sufficient for low-risk products, independent auditing by accredited organizations is mandatory for high-risk products. A positive assessment documents that the product can be sold safely in the EU market and meets all legal requirements.

How to Place the CE Certificate on the Product?

The CE mark must be placed on the product in a visible, legible and permanent manner. The position of the mark may vary depending on the product type, but it must be in a place that the user can easily see. In small-sized products, the mark can be placed on the packaging or on the documents provided with the product when it does not fit on the product itself.

Correct Use of the CE Mark

The CE mark can only be used on products that meet the requirements of the European Union. The presence of the CE mark on a product means that the manufacturer has declared that the mark is legally and appropriately used and that the product complies with the specified directives. However, the CE mark only shows that the product meets the essential requirements; it does not provide any quality or performance guarantee to consumers.

• CE Marking Placement Rules

The CE mark should preferably be placed on the product, or if this is not possible, on the packaging. The mark should be in a position that can be easily seen on the product or packaging (usually in the corner or on the back) and separate from other information.

• Dimension and Color Standards of the CE Mark

The specified standards must be followed when placing the CE mark. The height of the mark must be a minimum of 5 millimeters and it must be scaled while maintaining its proportions. The mark is usually printed in black or in a color that contrasts with the surface so that it can be clearly seen on the surface of the product. There is no special color requirement; what is important is that the mark is clearly visible.

CE Certificate Renewal Process

When the CE certificate expires, the product's compliance with current standards must be proven again. This process is carried out with the CE certificate renewal process. Below, you can find detailed information about the CE certificate renewal and product certification process.

How Long is the CE Certificate Valid?

The CE certificate validity period varies according to product groups. While there are products with a certificate validity period of 5 years, there are also products where this period can be extended up to 10 years. Products whose validity period has expired must undergo a conformity assessment again in order to continue using the CE mark. The validity period of the certificate is extended with the inspections carried out as a result of this assessment.

CE Certificate Renewal Procedures

The CE certificate renewal process consists of a series of tests and evaluations performed to keep the current document up to date. During this process, the product's compliance with current regulations and standards is checked. Renewal processes are similar to the initial certification process, but only for changing requirements and product updates.

• Documents Required for Renewing the CE Certificate

When applying for renewal, current versions of documents such as technical files, test reports and declaration of conformity used in the initial application must be submitted. If there are any changes made to the product, the relevant documents must also be attached to the application and the changes must be explained in detail.

• Tests and Inspections During the Renewal Process

During the renewal process, the product is tested especially for changes made to it and new requirements. Comprehensive examinations conducted by independent testing organizations verify that the product meets EU requirements in terms of safety, durability and environmental standards. These tests are mandatory for the product to continue to be sold on the European Union market.

CE Marking Example

By examining CE certificate examples, you can better understand the function and purpose of each component of the document. Below, we explain the basic information you will find in a CE certificate example:

• The "CE" mark at the top of the document indicates that the product complies with European Union standards.
• The numbers under the CE mark are the unique identification number of the notified body that issued the document.

To summarize;

•   CE certification is a mandatory certification system that demonstrates the compliance of products with the health, safety and environmental protection standards of the European Union.
•   The application process consists of basic stages such as preparation of necessary documents, product tests and creation of a technical file.
•   CE certification is mandatory for product categories such as electronic products, medical devices, toys and construction materials.

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