Quality

European CE Marking

The complete guide to the European quality mark

The CE mark of conformity came to the fore with the New Approach policy adopted in 1985. This mark is a mark of compliance with EU legislation indicating that products covered by the New Approach Directives comply with the relevant directives and have passed all required conformity assessment activities. The CE mark is a unit marking indicating that a product complies with the health, safety and environmental protection requirements set forth in the European Community directives.

The CE marking does not provide a guarantee of quality to the consumer, but only indicates that the product has minimum safety requirements. A product bearing the CE mark enters into free circulation between the member states of the European Union, so the mark also acts as a “product passport”. A product bearing the CE mark cannot be refused from EU and EFTA countries with legal justifications for the standards. The CE mark is a symbol indicating that a product conforms to the technical legislation of the Community.

Initially, the CE marking was used to form the initials of the words uygunluk Conformité Europeenne”, meaning European conformity, followed by the initials of the words “Community Europe”. The CE marking affixed to a product is a declaration by the responsible person that the product complies with all relevant provisions of the Community and that the necessary conformity assessment procedures have been completed.

The CE marking, which is a mandatory marking, must be affixed to the product before the product is put on the market or put into service by the manufacturer. Unless otherwise specified in the relevant technical regulation, it shall consist of CE letters at least five millimeters long and may be reduced where permitted by the relevant directives. This tag attached to the product or dashboard; It must be visible, readable and indelible.

If a product bearing the CE mark harms the life and property of the consumer or the environment, a fine of 7 thousand euros to 70 million euros will be imposed on each product. In addition, products with the CE mark of conformity may include a mark indicating another class of use.

The CE marking system is characterized by a normative understanding with conformity assessment methods that take into account the characteristics of products and the risks they carry. In this system, it is necessary to apply at least one of the modules to determine compliance with the relevant directives during the design and production phases of the product.

These modules cover different risk groups from A to H. Each module has classified the product according to the degree of hazard. The necessary test and certification studies to assess conformity to low-risk products are carried out by the manufacturer. In the case of high-risk products, these studies are carried out by organizations approved by the European Union.

Obtaining CE certification requires the manufacturer to prepare a technical file that includes the new approach directives and information indicating that the product complies with the essential requirements. This file may be part of the quality system documentation where the Directive provides for conformity assessment to be carried out based on the quality system. This commitment begins at the time the product is launched on the market, regardless of its geographical origin.

The technical file must be kept for at least 10 years from the date of manufacture of the product, unless the relevant Directive expressly provides for another period. This is the responsibility of the manufacturer or his authorized representative in the community. In some cases, it is the importer or the person who supplies the product to the community market.

As mentioned above, the CE marking is not allowed for low-risk products. The manufacturer declares that the product complies with the basic requirements and puts the CE mark on the product itself. In this regard, the responsibility is great. Therefore, they must assume this responsibility without prejudice to the principle of trust.

There are still a large number of cases pending before EU courts, where conformity is declared and CE marked but not found to meet basic requirements and collected from the market.

The CE mark, which is the manufacturer’s declaration of product safety assurance and is also referred to as product passport, is not a quality certificate. CE mark; the product on which it is located; Human, Animal, Phytosanitary, Safety and Environment and ensuring the use of a single mark throughout the European Economic Area.

The CE mark, which is very important to consumers, makes it easier for consumers to identify products that are classified by society as safe, and products with this mark prove compliance with packaging, labeling and safety-related standards to ensure high-quality products for consumers.

For more information, you can reach our team of experts from our contact addresses and phone numbers and you can get answers to all your questions.

Benefits of CE certification

The CE certificate is a safety mark that is used to make the regulations on technical structures simpler and more general in order to guarantee complete freedom of movement of products within the framework of compliance with EU technical legislation.

Products without the CE mark or CE certificate are not allowed to enter European markets. The CE mark or CE certification has many benefits for manufacturers.

The benefits of CE certification can be listed as follows;

The CE mark guarantees freedom of movement and marketing of the product in the countries of the European Union,
Industrialists are required to put the koymak CE mark on the product in order to market their products both nationally and internationally,
The CE mark indicates that the product conforms to the technical legislation of the European Union,
CE Mark, a kind of product as a passport,
The CE mark is definitely not a quality mark and warranty certificate,
The CE marking indicates the level at which quality begins.
CE marking, products below this level are considered unsafe, are not put on the market and are therefore considered to be of poor quality,
A CE Marked product cannot be rejected in the European Union

For legal reasons related to standards.

The CE mark is an indication of compliance with the New Approach Directives.
Products bearing the CE mark have the opportunity of free circulation and marketing in the countries of the European Union.
Industrialists must put CE markings on their products in order to market their products both inside and outside the country.
Products bearing the CE mark prove that this product has been manufactured in accordance with the technical legislation of the European Union.
The CE mark does not necessarily mean a quality certificate or a guarantee certificate, contrary to what is commonly believed.
Products below this level are considered unhealthy, unsafe and unqualified and should not be put on the market.
Products bearing the CE mark in European Union countries cannot be rejected on legal grounds according to the standards.
The CE mark is an indication of production in accordance with the New Approach Directives published in the European Union.

What is CE certification?

CE certification is a requirement for all products that are produced in the European Union and covered by one or more EU Directives as well as for the sale of products in non-EU countries within the European Union.

The CE mark is a sign of compliance with the European Union’s New Approach Directives, which indicate that the product attached to it is healthy and safe for humans, animals and the environment. A product falling within the scope of one or more of the New Approach Directives that now finds No. 25 cannot enter the EU market without being CE marked.

The European Union has launched a CE certification program to make trade between member states easier and cheaper. This means that the manufacturer claims that its product complies with the minimum legal requirements set by the European Union directives in the areas of health and safety.

Customers often see the CE marking on one product as meeting specified minimum standards, which indicates the lowest indication of quality that may be missing from other products.

The European Union has taken a number of measures to facilitate the free movement of goods throughout the EU and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Guidelines. The New Approach Guidelines provide control over product design and, above all, aim for harmonization across Europe with regard to product safety.

The directives cover a wide range of products, including toys, medical devices and compression equipment. The primary goal is to ensure that products are well designed and safe for the user.

Across Europe, where the New Approach Directive is being applied, manufacturers are required to affix the CE marking to their products. CE marking requirements may vary from directive to directive, even within the same directive.

CE marked product; It is an indication that the product meets the directives and rules of the European Union. For example, an electrical product is required to comply with the European Low Voltage Directive and the EMC Directive. A product may fall under more than one directive.
With the CE mark, the manufacturer declares that the product meets basic safety requirements and does not harm the environment or humans, which replaces the product as a passport, making it easily tradable in the European market.

Who can get CE certification?

The European Union has taken a number of measures to facilitate the free movement of goods throughout the EU and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Guidelines. The New Approach Guidelines provide control over product design and, above all, aim for harmonization across Europe with regard to product safety.

The directives cover a wide range of products, including toys, medical devices and compression equipment. The primary goal is to ensure that products are well designed and safe for the user.

Across Europe, where the New Approach Directive is being applied, manufacturers are required to affix the CE marking to their products. CE marking requirements may vary from directive to directive, even within the same directive.

The European Union has classified products according to risk groups and issued a number of regulations to ensure that these products comply with safety, environment, health and consumer protection standards. These regulations are collectively associated with Product Group 23 and are commonly referred to as the New Approach Directives. Based on the subjects of these directives, manufacturers who can obtain CE certification are revealed.

Companies that can place the CE mark on their products can be listed as follows:

  • Building materials manufacturers
  • Personal protective equipment manufacturers
  • Wireless communication equipment manufacturers
  • Passenger car manufacturer
  • Companies producing explosives for civilian use
  • Non-automatic weighing tools
  • Companies producing equipment used in explosive environments
  • elevator manufacturers
  • freezer manufacturers
  • pressure vessels
  • active medical devices
  • Medical device manufacturers
  • Low voltage equipment manufacturers
  • Pressure vessels are simple
  • Gas burner manufacturers
  • Hot water boilers
  • Manufacturers of electromagnetic properties
  • machine manufacturers
  • In vitro medical diagnostic equipment manufacturers
  • game manufacturers
  • Pleasure boats

The product groups can be listed as follows

  • Implantable medical devices
  • Gas burning devices
  • Ski lifts
  • Electromagnetic devices
  • Products used in explosive atmospheres
  • Civilian explosives
  • Hot water boilers
  • In vitro diagnostic medical equipment
  • elevators
  • low voltage devices
  • mechanism
  • Measurement tools
  • medical equipments
  • Non-automatic weighing tools
  • Personal protective equipment
  • pressure equipment
  • Radio and telecommunications equipment
  • Play
  • Pressure vessels are simple

Depending on the risk levels of the products, these manufacturers place the CE mark on the products themselves or after they have been examined by a certification body, they place the CE mark on the products according to the results of this examination. The European Union has classified products according to hazard groups A to H in the application of the CE marking.

what

Is the CE education system?

The CE mark is a sign of compliance with the European Union’s New Approach Directives, which indicate that the product attached to it is healthy and safe for humans, animals and the environment. A product falling within the scope of one or more of the New Approach Directives that now finds No. 25 cannot enter the EU market without being CE marked. The CE mark is the health and safety mark applied under the Yeni New ğu approach established by the European Union in 1985 in order to ensure the free movement of goods. It is intended to use the standard EU marking to indicate compliance with EU directives, rather than the various conformity marks used in the EU.

While the CE marking gives manufacturers an obligation to ensure that their products comply with certain standards and requirements, it enables users to know that the product complies with basic quality and safety standards. The CE mark is known as the symbol of quality by many users, and the CE certificate is a mark indicating that the products will not harm human life, property, plant and animal existence, and the environment if they are used for their intended purpose, in other words, the product is a safe product.

CE certification is a requirement for all products manufactured in the EU and covered by one or more EU Directives, as well as for the sale of products in non-EU countries within the EU.

The European Union has launched a CE certification program to make trade between member states easier and cheaper. This means that the manufacturer claims that its product complies with the minimum legal requirements set by the European Union directives in the areas of health and safety.

Customers often see the CE marking on one product as meeting specified minimum standards, which indicates the lowest indication of quality that may be missing from other products.

The main advantage of EU regulations is that products bearing the CE mark are limited to basic requirements that impose high health and safety requirements. Prerequisites indicate the risks inherent in a product, so manufacturers must conduct risk analyzes and technical documentation if these are not included in the harmonized standards they use.

Prerequisites do not specify results to be achieved or risks to be eliminated, but they do not provide technical guides or hints on how to deal with them. Producers can access accurate solutions and application details to ensure compliance with essential requirements using the relevant harmonized standards or specifications.

The CE mark is not directly related to Quality Management Systems (TS EN ISO 9001). The CE marking indicates that a product has been designed and manufactured in compliance with the EU’s New Approach Directive and related harmonized European standards. In the modular system, quality management systems are shown to be essential for some groups of products.

What does the CE education system coverage standard include?

CE Certification (Mark) Since there is a mark attached to products within the scope of a number of New Approach Directives that are required to comply with the European Union, it is essential that products within the scope of said legislation and to be placed on the market in EU Member States bear this mark.

The customs union that entered into force between the European Union and our country at the beginning of the year 1996 anticipates the free movement of goods with the exception of agricultural products. 3 in our country’s relations with the customs union with the European Union. It has gained different location of country. These differences with the sale of goods in the EU member states to enter our competition as well as full, verified in the Union standards in the production of goods has become a necessity in terms of Turkey. In this context CE certification has been an integral part of the production process in Turkey and in this way will improve the quality of Turkish goods.

At this point, before the 23 product series manufacturers in Turkey, which is only mandatory in exports to the European Union CE mark (document), will be marketed in our country after this date will become mandatory for products.

Products in the 23 product group where the CE marking is mandatory for European Union countries cannot be sold without CE marking. These regulations have been applied in our country since 2002. Products belonging to these product groups can no longer be introduced in our country to the markets of EU countries without CE marking and cannot be put on the market in our country. These markings define the scope of the CE marking system.

Here are the 23 product line, issued by the European Union as New Approach Directives and which require CE marking, and the organizations responsible for the compliance of these product groups with EU legislation.

Separate regulations are presented for each of the product groups listed below.

The product groups responsible for the Ministry of Industry and Trade are:

  • low voltage devices
  • Pressure vessels are simple
  • Gas burners
  • Hot water boilers
  • Electromagnetic compatibility
  • mechanism
  • Civilian explosives
  • Non-automatic weighing tools
  • Equipment used in explosive environments
  • elevators
  • Freezers
  • pressurized containers
  • Noise from outdoor equipment to the environment
  • Energy efficiency of fluorescent lamps
  • Product groups responsible for the Ministry of Health:
  • Active implantable medical devices
  • medical equipments
  • In medical laboratory diagnostic devices
  • Play

Product groups for which other organizations are responsible:

Pleasure boats (Undersecretary of the Ministry of Maritime Affairs)
Building Materials (Ministry of Public Works and Settlement)
Personal protective equipment (Ministry of Labor and Social Security)
Broadcasting and Telecommunications Terminal Equipment (Communications Authority)
Vehicles that move on cables to transport passengers (Ministry of Industry and Trade)

What are the basic principles of the CE marking system?

The CE mark is a mark of compliance with the European Union’s New Approach Directives, which

Indicates that the product with which it is attached is safe for the environment in which it is used. A product may enter more than one new approach directive, and the CE marking is attached to the product
This is it.

Directive compliance means meeting the essential requirements of the directives by following the relevant conformity assessment procedures specified in the directives. These prerequisites define product safety requirements. However, the basic requirements do not directly specify the requirements for performance characteristics and product quality. Therefore, the CE marking is for product safety and is primarily intended for free movement within the European Union.

When introducing their products to the EU market, manufacturers must ensure that each stage of these products and production processes are in compliance with the provisions of the regulations and take the necessary measures.

In fact, the measures included in the regulation and envisaged to be implemented also include the basic principles of the CE marking system.

Carry out or carry out a conformity assessment in accordance with the provisions of the relevant regulation
Preparation of technical documents
Preparation of the European Union declaration of conformity
Provide operating instructions and safety information in a way that large consumers can easily understand
Meet the tracking requirements described below:
Maintain technical file and EU Declaration of Compliance throughout 10
For a description of the product including type, batch and serial number
To show the name, registered name or registered trademark of the manufacturer on the product or on accompanying documents.
We attach the CE mark on the product

How to install CE product certification system?

A company that decides to do business in the European Union and wants to add the CE marking to its products must have 23 product groups covered by the EU New Approach Directive.

Next, the company should prepare a technical document related to the products. This document should contain design studies, production processes and operational information related to the product to be CE marked. In fact, this prepared technical file forms the basis of the studies.

If the company wants to add the CE mark, no matter which product is in the hazardous group or the product is in the risk-free group, the technical file of the products must be ready.

In applying the CE marking, the European Union has classified products according to risk groups A to H as follows:

A: In-house production control
A1: Supervision of internal control of production and testing of products
A2: Product control through internal production control and unexpected visits
B: EU type examination
A: Compliance with EU type of internal production control
C1: EU type compliance and product testing in-house production supervision
C2: Product control through EU type compliance and random visits in internal production control
D: Compliance with EU type based production quality assurance
D1: Production quality assurance
E: Compliance with EU type based product quality assurance
E1: Quality assurance for product final inspection and testing
F: EU type based product verification
F1: Compatibility based on product verification
G: Suitability based on unit verification
H: Compliance based on complete quality assurance
H1: Fit on the basis of a complete quality assurance and design review

The manufacturer is responsible for putting the products on the market with the CE mark (certificate) and for affixing the CE mark on the product. Various manufacturer alternatives are provided to attach this tag to the product.

Low risk products

Many products are included in the low risk product groups in terms of safety. Therefore, by making a declaration after the manufacturer has carried out a conformity assessment; Indicates that the product complies with mandatory safety, health, environmental and consumer protection standards. This statement should be drawn up according to the rule.

High risk products

The manufacturer’s advertisement is insufficient for these products. In this case, the products must be tested by the notified bodies. As a result of a notified body inspection, a manufacturer may affix the CE mark to its product. Manufacturers of all systems and units produced for use in the final product must send to the manufacturers to be combined a file and declaration of components and components in accordance with the terms of the relevant directive (decree). Organizations that produce components or components for integration cannot have the CE marking on their products.

What is the CE product certification process?

The CE certificate is a safety mark that is used to make the regulations on technical structures simpler and more general in order to guarantee complete freedom of movement of products within the framework of compliance with EU technical legislation.

The CE mark is a mark of compliance with the European Union’s New Approach Directives, indicating that the product it comes with is safe for the environment in which it is used. Any product may enter more than one New Approach Directive, and the CE mark affixed to a product that meets the necessary requirements indicates that the product complies with all of these Directives. Directive compliance means meeting the essential requirements of the directives by following the relevant conformity assessment procedures specified in the directives. These prerequisites define product safety requirements.

However, the basic requirements do not directly specify the requirements for performance characteristics and product quality. Therefore, the CE marking is for product safety and is primarily intended for free movement within the European Union.

The manufacturer decides the product labeling requirements according to the scope of the directive and the hazard situation and is obliged to take the necessary steps. The product whose risk is identified is subject to conformity assessment by the notifying body. Next, the labeling and certification process for the product is determined.

practical

Certification is generally as follows.

definition of applicable directive;
The first step is to determine whether the product has CE marking requirements. Products falling into at least one of the sectorally published directives must bear the CE mark. A product may also enter more than one directive if it is not covered by the directive then the product does not have to bear the CE mark.

Determine routing requirements:
The evaluation of each directive may vary according to the area of use and the risk factor of the product. Each directive has a number to meet before the product is put on the market.

Conformity assessment
Define product requirements for risk assessment and conformity assessment body.
Product evaluation
Establish a factory production control system for third party audits
EC type tests for third party inspections

Conformity assessment of the product
It must be determined whether the product complies with all the requirements covered by the directive. For example, product type tests or compliance with conditions necessary to ensure.

preparation of technical documentation;
Technical files must be prepared in accordance with the rules and directives to which the products are subject. This information should include product design and development and product details.

information required in the technical file;

Technical information about the product
Technical drawings, circuit diagrams and photos
All component information about the product
Specifications for the declaration of conformity
Product test reports
directions
European Commission declaration of conformity
This information must be kept for one year from the last batch of product.

A video explaining the European quality mark

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