The CE mark is a symbol that manufacturers place on the products in order to market their products in European Union countries. The CE marking is mandatory for products covered by one of the European Union directives.
The CE mark means that the products comply with the European Union's health, safety, performance and environmental requirements and that the manufacturer is responsible for all such responsibilities. The CE marking is mandatory for all member states of the European Union. In addition, countries such as Iceland, Norway and Liechtenstein and Switzerland are looking for CE marking on products.
In our country, the relevant directives have been adapted to our own domestic law within the scope of the harmonization studies with the European Union and the application of CE marking has become obligatory. As a result, the CE marking gives 500 access to a market of more than million consumers.
CE marking is quite different from other certification systems. No organization is authorized to use the CE marking. The manufacturer is directly responsible for the correct use of the CE marking. The manufacturer is ultimately responsible for using the CE marking, even if it is installed inside or outside the European Union. However, in terms of its meaning, the CE mark is much more than a symbol.
Therefore, the first thing manufacturers should do is to determine whether their products require CE marking. For this, it is necessary to understand whether the products are covered by one or more of the relevant European Union directives. If any of these directives fall within the scope, the product must be CE marked.
These directives are:
Low voltage (2006 / 95 / EC)
Simple pressure vessels (2009 / 105 / EC, formerly 87 / 404 / EEC)
Eco design for energy related products (2009 / 125 / EC)
Noise emission for outdoor equipment (2000 / 14 / EC)
Toy safety (2009 / 48 / EC, 88 / 378 / EEC, 93 / 68 / EEC)
Construction products (89 / 106 / EEC, 93 / 68 / EEC)
Electromagnetic compatibility (2004 / 108 / EC)
Machines (2006 / 42 / EC)
Personal protective equipment (89 / 686 / EEC, 93 / 68 / EEC, 93 / 95 / EEC, 96 / 58 / EC)
Non-automatic weighing instruments (2009 / 23 / EC former 90 / 384 / EEC)
Devices burning gas fuels (2009 / 142 / EC old 90 / 396 / EEC)
Hot water boilers (liquid or gas fuels) (92 / 42 / EEC, 93 / 68 / EEC, 2004 / 8 / EC, 2005 / 32 / EC)
Explosives for civil uses (93 / 15 / EEC)
Medical devices (93 / 42 / EC, 98 / 79 / EC, 2000 / 70 / EC)
Active implantable medical devices (90 / 385 / EEC, 93 / 42 / EEC, 93 / 68 / EEC, 2007 / 47 / EC)
In vitro diagnostic medical equipment (98 / 79 / EC)
Equipment used in explosive atmospheres (94 / 9 / EC)
Recreational boats (94 / 25 / EC, 2003 / 44 / EC)
Lifts (95 / 16 / EC)
Pressure equipment (97 / 23 / EC)
Radio and telecommunications terminal equipment and satellite ground stations (99 / 5 / EC)
Cable car facilities to transport people (2000 / 9 / EC)
Measuring instruments (2004 / 22 / EC)
Pyrotechnic substances (2007 / 23 / EC)
The New Approach Directives are documents containing the legal regulations issued by the European Commission on the CE marking. These documents contain information about the CE marking requirements and the processes to be followed in order for certain products to be placed on the market in the European Union. It is the responsibility of the manufacturer to determine whether a product complies with the CE marking requirements.
The CE mark is accepted as a kind of commercial passport for European Union markets. Products with CE marking have the opportunity to move freely in all countries of the European Union. Therefore, the biggest advantage for manufacturers is that there is a single set of requirements and procedures that must be followed to design and manufacture a product across the European Union. Thanks to these directives, a wide variety of contradictory and national regulations have been abolished. Therefore, the products do not need to be adapted to the different special requirements of the member states of the European Union.
In addition, if a single set of requirements and procedures are followed, the products become safer for consumers and the demands for damage and liability are gradually reduced.
A directive is the legislative action of the European Union, which requires the member states of the European Union to adapt their national laws in order to achieve a certain result harmonized with the criteria in this field. For example, for products covered by the electromagnetic compatibility directive, the electromagnetic compatibility directive 2004 / 108 / EC has been issued with the aim of ensuring that member countries meet the specific requirements of electrical appliances covered by this scope.
The electromagnetic compatibility directive primarily limits the electromagnetic emissions of an electronic equipment to ensure that it does not disturb any other electronic equipment when used as intended. The directive also governs the immunity of such equipment to interference and seeks to ensure that radio equipment is not disturbed when used as intended.
It is sometimes difficult to determine whether a product is covered by one or more directives. All directives may need to be reviewed to know which directives are covered by their product characteristics.
After determining which directives or directives the products are covered by, the next step is to assess whether the product complies with the applicable directives and how to make it suitable if not.
Each directive details what is legally required in the form of basic conditions. These requirements are naturally very general. The directives do not include details of how the product is designed to meet basic requirements. In order to develop harmonized standards, tasks such as CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization) have been assigned. The European Commission's official website should be consulted to see if a compliant standard exists for products.
In short, the New Approach Directives published in the European Union countries came into force with the aim of ensuring minimum product safety and facilitating the free movement of products within a single market. These directives contain a number of basic requirements for safety, health, the environment and consumer protection.
The New Approach Directives introduce a set of basic requirements in parallel with the CE marking on a product. The CE marking is therefore a mandatory label for products covered by one or more directives. In other words, the CE marking is a mandatory mark indicating that products can be placed on the market in the European Union. It expresses the conformity approvals of the manufacturers in order to ensure that the product complies with all the principles contained in the relevant directives. These principles are based on safety, human health and consumer protection.
The commitments of the member states in the CE marking application are:
Check whether the manufacturer is justified in placing the products in question in accordance with the essential requirements of the directive or directives
Ensuring the free movement of products with CE marking, regardless of origin
The CE marking on the products may be the responsibility of the manufacturer in accordance with the criteria contained in the relevant directive and, depending on the nature of the risks to the products, or the CE marking on products following conformity checks, such as tests, measurements, manufacturing control and quality assurance, may need to be
In summary, the CE marking has two main benefits for businesses and consumers:
Businesses can put their CE marked products on the market in European Union countries without any restrictions.
Consumers benefit from the same health, safety and environmental protection throughout the European Union
First, it is determined whether the organization meets the mandatory requirements of the standard and whether to proceed to the next stage.
It is checked whether necessary procedures and audits have been developed and your institution's readiness for evaluation is reviewed.
The findings that arise in the first two stages are evaluated and after all corrective actions are reviewed, document preparation is started.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
