What is CE Certificate? How to Obtain CE Certificate?

 

What is CE Certificate? The economy of European countries, which collapsed after the second world war, gained momentum with the industrial revolution in the world trade, which gained momentum with the industrial revolution. Countries that lost their protectionist policy in the free movement of imports and products as a result of the elimination of obstacles such as customs clearance costs in the free movement of machinery, products and goods in world trade, compatibility with local standards of the relevant countries, lack of infrastructure, started to use technical requirements created for reasons such as human health and safety, environment, animal and plant life and health and consumer protection. In the case of basic criteria such as basic health and safety, it has become a necessity to carry out studies to remove these obstacles while selling products to countries that impose technical barriers in order to reduce and subsequently abolish technical barriers.

CE marking is a health and safety marking applied in the context of the “New Approach” established by the European Union in 1985 to simplify and generalize the legislation on the technical characteristics of products in order to ensure the free movement of products. The New Approach regulations, in which conformity assessment procedures and basic health and safety safety requirements are determined, stipulated that these products comply with the basic health and safety safety requirements of the regulations and requested conformity assessment studies and certification of the product’s compliance with the directive. In this context, if compliance with the New Approach Directives is documented, it has been decided to affix the “CE” marking on the product to indicate product conformity.

The CE marking, which is the manufacturer’s declaration of conformity and is described as a kind of passport of the product, should not be considered as a quality mark. The CE marking indicates that the product on which it is located is produced in accordance with the basic requirements of the technical regulations prepared in a way that does not harm human, animal, plant health and safety and the environment, and the CE marking is attached as shown below.

With Article 8 of the Association Council Decision No. 1/95 of the Customs Union Agreement between Turkey and the European Union, it was deemed appropriate that the laws and regulations of the European Union for the removal of technical barriers to the free movement of products be put into force at the same time as the European Union, together with local legal regulations by Turkey. In this context, with the Council of Ministers Decision No. 97/9196, Turkish public institutions that will harmonize the technical harmonization regulations have been identified.

The Technical Legislation System called New Approach Directives in the European Union, CE certification obligation has been transformed into National Legislation in accordance with the Customs Union agreement signed between Turkey and the EU in 1996 and the Association Council Decision No. 1/95. In this framework, the Law No. 4703 on the Preparation and Implementation of Technical Legislation on Products was published on July 11, 2001 and entered into force on January 11, 2002. During the transposition of the EU New Approach Directives into national legislation, the implementing regulations required for the implementation of Law No. 4703 were published in the Official Gazette dated January 17, 2002, effective as of January 11, 2002. The Law left the nationalization of the EU New Approach Directives to the Competent Authorities in order to complete these works. The Competent Authorities have published the directives for which they are responsible and ensured their entry into force and thus CE marking has become a mandatory practice in Turkey.

CE marking is not a marking that can be applied for all products or product groups placed on the market. It is a mandatory application if the product placed on the market is included in the scope of the New Approach Directives (Regulations) in Table 1 below. CE marking cannot be affixed to products not included in Table 1. Since the CE certificate symbolizes the conformity of the product with the relevant directive(s), affixing CE marking on products that are not included in Table 1 constitutes an action contrary to existing laws and regulations as it is misleading information for the consumer. While the harmonization process was in progress, Law No. 4703 on the Preparation and Implementation of Technical Legislation on Products” was published in the Official Gazette No. 24459 dated 11 July 2001 and entered into force on 11 January 2002 in order to establish the necessary legal infrastructure for the effective implementation of the technical legislation to be adopted. On the other hand, among the regulations determining the implementation procedures and principles of this Law,

* Regulation on Conformity Assessment Bodies and Notified Bodies,

* Regulation on the Attachment and Use of the CE Conformity Mark on the Product

* The Regulation on Market Surveillance and Inspection of Products was published in the Official Gazette dated January 17, 2002 and numbered 24643 and entered into force as of January 11, 2002.

The entry into force of the Law No. 4703 and the regulations issued pursuant to this Law as of January 11, 2002 does not mean that CE marking will be compulsory for products within the scope of the “New Approach Directives” in Turkey as of this date and that CE Certificate will be provided to the products according to the relevant regulations. It is not possible to make CE marking compulsory in Turkey for the products within the scope of the “New Approach Directives” and supplied to the domestic market until the EU directives on these products are put into force as domestic legislation by the relevant institutions in Turkey. After the harmonization of the legislation is completed, it will not be possible to place products that do not bear this mark on the domestic market. In order for the CE marking of the products to be produced in Turkey and supplied to the domestic market to be compulsory, the technical legislation prepared by the relevant Ministries and public institutions and stipulating the CE marking of the products has entered into force in Turkey.

Modular Approach for CE Certification in the European Union:

The Modular Approach is a system created by the drafters of the CE Certificate and CE Certification regulations. The committee that regulates the regulation can determine the conformity assessment procedures by evaluating a module or combination of modules within the scope of the regulation according to the characteristics of the machinery and products in this sector and the risk they carry in order to ensure human, animal health and safety and environmental protection in an area where it wants to regulate. In general, there are 8 modules from A to H in the relevant regulations for CE marking and CE certification. CE certificate is obtained according to the following modules:

MODULE A : Internal Production Control

MODULE B : Type examination

MODULE C : Declaration of Conformity to Type

MODULE D : Production Quality Assurance

MODULE E : Product Quality Assurance

MODULE F : Product Verification

MODULE G : Unit Verification

MODULE H : Full Quality Assurance

5 Modules A, G and H include both design and production phases, Module B includes only the design phase and Modules C, D, E and F include only the production phase. By using the modules, the Regulatory Committee gives the manufacturer more than one alternative to prove that the product complies with the technical regulations. According to the nature of the product, the appropriate modules are specified in the regulations for the product. In the regulation of the product, there may be more than one combination of modules and the manufacturer can either use one of them for CE certification or complete the product conformity process by meeting the basic requirements of the European Standard.

Requirements for affixing the CE marking and its use on products with CE Certificate:

If the product to be provided with the CE certificate is subject to more than one technical regulation requiring the CE marking to be affixed, the CE marking indicates that the product complies with the provisions of all relevant technical regulations.

CE Marking;

1) Unless otherwise specified in the relevant technical regulation, it consists of the letters “CE” at least 5 mm in length.

2) The CE marking template in the Regulations may be reduced or enlarged, depending on its proportions and shape,

4) It is prepared in a quality that is visible to the naked eye from 1.5 meters, readable and will not be erased with ethyl alcohol and CE marking is attached.

1. c) the CE conformity marking shall be affixed at the end of the production control phase.
   d) where required by the relevant Regulation, the CE marking shall be accompanied by the notified body registration number issued by the Commission of the notified body carrying out the CE Certification procedure involved in the production control phase.
   e) Where it is necessary to indicate the characteristics of the use of certain products, a pictogram or other marking indicating the category of use may be placed after the CE marking and the identification registration number of the notified body issuing the CE Certificate.
   f) Products may not be affixed with other markings that may mislead third parties about the meaning and shape of the CE marking.
   g) Signs indicating conformity with the Regulation and the standard may be affixed to the product, its packaging or attached document, provided that they do not damage the visibility and legibility of the CE marking.
   h) The CE marking is affixed by the manufacturer. The number of the notified body is affixed by itself or by the manufacturer under its own responsibility.3) The CE Marking is affixed to the product or information label. If this is not possible due to the nature of the product, it is affixed to its packaging and, where the relevant technical regulation requires the product to be accompanied by any documents, to these documents,

Use of CE marking and Importance of CE Certificate

Under the New Approach directives, the use of the CE mark and the CE Certificate requires first determining which regulation(s) the product falls under. Some products may be subject to multiple regulations due to their scope, function, operating environment, and characteristics. For example, a machine is evaluated under the Machinery Safety Directive, but due to the electronic components and units it contains, it is also evaluated under the Low Voltage and Electromagnetic Compatibility Directives. If it is intended for use in explosive atmospheres, it is evaluated under the ATEX Directive, and CE certification is obtained. The relevant directives do not directly refer to products; instead, they describe product characteristics. Therefore, the manufacturer/authorized body will decide whether the product falls under the scope of the directives by reviewing these scopes. If it is determined that the product falls under the scope of the regulations, the harmonized EU standards (norms) mentioned in the regulations must be obtained to determine how the basic safety requirements mentioned in the regulations will be met and how the conditions required for the CE Certificate will be fulfilled. After determining the regulations and standards applicable to the product, it is necessary to identify which module or modules should be applied for the use of the CE mark, the procedures and processes to be followed, prepare test equipment if required, and identify an accredited body for obtaining the CE certificate. While following the procedures in the modules, depending on the risk factors of the product, the CE certification and CE certification activities to be carried out on the product may be required to be performed by a notified body, or there may be product groups that the manufacturer can perform. A technical file containing the documents obtained as a result of the activities required to obtain the desired CE certificate for the product (testing, inspection, audit, and certification) will be prepared by following the procedures of the module or modules specified in the regulations. After completing the CE certification activities, the manufacturer prepares a written declaration of conformity and uses the CE mark. The technical file and the declaration of conformity shall be kept for a period of 10 years from the date of manufacture of the final product, unless otherwise specified in the relevant technical regulation, for submission to the competent public authority for inspection.

Preparation of the Technical File, Declaration of Conformity, and CE Certification

Technical File: Manufacturers or importers must prepare a technical file in order to market their products in the EU.

The technical file is a document containing reports, test results, inspection results, and other documents demonstrating that the product has been manufactured in accordance with the requirements specified in the relevant technical regulations, and containing information on the design, manufacture, and operation of the products. It serves as the product’s passport and international identity. The technical file must be kept up-to-date to ensure that the risks associated with the product are minimized and that the basic safety requirements are met to the greatest extent possible. In other words, after the technical file is prepared and the CE mark and CE certificate are obtained, if any risks are identified, measures should be taken to address them, and risks arising from changes in the design and raw materials or semi-finished products used in the product should be eliminated, and the necessary tests should be conducted regularly. The test and inspection reports and documents included in the technical file must be legible, free of any markings or handwriting, and signed by authorized persons. The technical file must be kept in the company’s archives for 10 years from the date of manufacture of the final product, unless otherwise specified in the relevant technical regulations, for submission to the competent public authority for inspection.

The general content of the technical file is as follows:

• General description of the product, descriptions explaining the product’s operation,
• Drawings related to design and production, diagrams of parts, modules, and circuits, and information on operating procedures,
• A list of the harmonized standards applied, and in cases where these standards have not been applied or cannot be applied, explanations of the solutions adopted to meet the essential requirements of the technical regulation,
• Results of the design calculations and inspections carried out,
• Test reports,
• Turkish or original user manuals,
• Quality Management System (ISO Series Quality Management System certificates if required by the relevant product regulations),
• Turkish or English assembly manual for the product,
• Results of product safety tests following changes in equivalent materials and raw materials used in the design or production of the product, and
• Declaration of Conformity and CE Certificate
• Declaration of Conformity

The manufacturer and importer declare that the product has been manufactured in accordance with the essential requirements of the relevant technical regulations. This declaration shall include the following information.

• Name and address of the manufacturer or authorized representative (or importer),
• Product description (structure, type, serial number, etc.),
• All provisions to which the product complies,
• If applicable, the name and address of the Notified Body that approved the product’s conformity, along with the number of the EC type examination certificate,
• If applicable, the numbers of the harmonized European standards used as the basis for production and conformity assessment,
• If applicable, references to national standards and technical specifications used,
• Name and signature of the person authorized to make the declaration on behalf of the manufacturer or their authorized representative/importer,
• The last two digits of the year in which the CE mark was affixed.
• Information on the Conformity Assessment Body and CE Certificate
• Technical European Union Regulations prepared for the CE Certificate
• 305/2011/EU Construction Products Regulation
• 2006/42/EC Machinery Safety Regulation
• 2014/35/EU Low Voltage Equipment Regulation
• 2014/30/EU Electromagnetic Compatibility Regulation
• (2004/22/EC) Measurement and Measuring Instruments Inspection Regulation
• 93/42/EEC Medical Devices Regulation
• (98/79/EC) In Vitro Diagnostic Medical Devices Regulation
• 2017/746/EU Implantable Active Medical Devices Regulation
• 2000/14/EC Regulation on Noise Emission in the Environment
• 2009/48/EC Toy Safety Directive
• 2014/29/EU Simple Pressure Vessels Directive
• 2016/425/EU Personal Protective Equipment Directive
• 2016/426/EU Regulation on Gas-Fired Appliances
• 92/42/EC Regulation on New Hot Water Boilers
• 2014/68/EU Pressure Equipment Regulation
• 2014/33/EU Elevator Regulation
• 2016/424/EU Cableway Installations Regulation
• 2014/31/EU Regulation on Non-Automatic Weighing Instruments
• 2014/34/EU Regulation on Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres

TESTPLUS, with its team of expert engineers, conducts comprehensive tests using state-of-the-art combined electrical safety test equipment and mechanical test equipment to ensure compliance with standards and regulations, and provides detailed reports. Through accredited partner certification bodies listed in the European Union’s NANDO database, we facilitate the issuance of CE certificates.

The CE Certificate replaces the various conformity marks previously used throughout the European Union and serves as a passport for products in the European Union market, indicating that they comply with European Union regulations and are safe. A product bearing the CE mark has the freedom to circulate freely within the European Union without any restrictions. A product with a CE certificate cannot be stopped at customs or have its sale restricted within the Union. Products covered by the CE mark cannot be placed on the market without this mark in the EU and the Turkish domestic market. This rule applies to both products manufactured within the Union and those imported from third countries.