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CE Mark / CE İşareti

CE Mark

The CE mark (CE Mark) appears on certain products and indicates that the product in question complies with European health, safety and environmental protection standards. CE marking, which is not a quality certificate or indicator, is one of the top priority requirements for supplying products to the EU market. It enables various products, machines, devices and equipment to be sold freely in the European Economic Area (EEA). By placing the CE mark on their products, manufacturers declare that the product complies with all legal requirements defined for this mark and can be sold freely throughout the EEA. This requirement also applies to products manufactured in other countries but sold in the EEA. In other words, if a manufacturer outside the EEA wants to produce a product that requires CE Certificate and put it on the EU market, it must document the product and sell it by placing the CE mark on it.

What is CE Mark?

“CE” consists of the initials of the French expression “Conformité Européenne”. This expression means European conformity in Turkish. The CE mark on a product indicates that the manufacturer or importer of that product has certified that it complies with the relevant EU legislation and that the product can be sold anywhere in the European Economic Area (EEA). It is legally illegal to CE mark or offer for sale a product that does not meet the requirements and/or is not covered by an EU regulation.
One of the most important things to know about marking / labeling is this: A mark does not indicate that the EU or any other authority has approved a product as safe or compliant. EU requirements may include work to be done on safety, health and environmental protection and/or other product-related issues. If stipulated in any EU product legislation, CE certification may require evaluation by "notified bodies" or production according to a certified production quality system. In cases where notified bodies are required to participate in the process, the registration number of the notified body included in the conformity assessment is also indicated after the CE marking.
CE marking is not required for all products to be traded in the EEA. Only the product categories subject to the relevant regulations or regulations must bear the CE mark and only these products are allowed to enter the EU market.

CE Mark Scope

We can summarize the product groups that require CE marking as follows:
• Active implantable medical devices
• Low voltage
• Elevators
• Pressure equipment
• Simple pressure vessels
• Restriction of dangerous substances in electrical and electronic equipment
• Electromagnetic compatibility
• Eco design of energy related products
• Gas fuel burning devices
• Recreational boats
•    Fireworks
• In vitro diagnostic medical devices
• Cable car installations designed to transport people
• Construction products
• Personal protective equipment
•    Machines
• Noise emission in the environment
• Non-automatic weighing instruments
•    Toys
• Measuring instruments
• Equipment and protective systems intended for use in potentially explosive atmospheres
• Radio equipment
• Hot water boilers
• Explosives for civilian uses
• Medical devices

The CE mark must be affixed to the product by the manufacturer or its authorized representative in the European Union in a visible, legible and indelible manner in accordance with its legal format. If the appearance and workmanship of a product do not allow this mark to be affixed to the product itself, the mark must be affixed to the product´s packaging or accompanying documents. By marking the product, the manufacturer of a product undertakes and guarantees that all tests, evaluations, calculations, examinations and measurements related to the product comply with the requirements of all directives applicable to the product.
The CE mark is placed on the product by the manufacturer or its authorized representative, who must verify that the product meets all marking requirements. If a product is defined as one of the products in the minimum risk group in the regulation it covers, the declaration of conformity can be prepared directly by the manufacturer and the manufacturer can make the marking himself. This is only available for products with minimal risk in their use and is clearly stated in the relevant directive according to the product category.
Where notified bodies are involved in the CE certification process, a conformity assessment procedure needs to be operated. The procedures (modules) defined in EU regulations for issuing CE Certificate to products are as follows:

• Module A: Internal production control
• Module B: EC type examination
• Module C: Type conformity
• Module D: Production quality assurance
• Module E: Product quality assurance
• Module F: Product validation
• Module G: Unit verification
• Module H: Full quality assurance

How to Get CE Mark?

Works to be done by an organization that wants to get CE Certificate / CE mark;
• product type, features, degree of risk,
• to manage its scope,
• scope of conformity verification studies such as testing, analysis, calculation, etc.,
• documentation framework,
• whether a notified body will be involved in the process
may vary depending on the subject, etc. However, we can summarize the works that are absolutely necessary for marking as follows:
• It should be determined under which EU regulation the product will be evaluated.
• The requirements of this regulation and the standards to which the regulation refers should be set forth.
• Tests, analyses, examinations and/or audits to be carried out within this scope should be determined.
• Technical file should be prepared. Depending on the product to be documented and the conformity assessment procedure, the following documents may need to be included in this file:
o Product information; brand, model, type etc. Documents showing the intended use are also required.
o General and detailed technical drawings of the product; electronic, mechanical and hydraulic diagrams and explanatory visuals as the case may be
o Sub-component list of the product, if any; technical documents on critical elements and materials contained
o All test, analysis, calculation, measurement, evaluation and inspection reports
o Instructions used in the design, manufacture, storage, etc. of the product
o Product user manual and, if necessary, installation, repair and maintenance procedures
o EU declaration of conformity
o If the CE Certificate is issued based on the approval of a notified body, the reports prepared by this body
This file should be kept for 10 years, to be submitted to the competent authorities when necessary.
• CE mark can be placed on the product if all studies are completed and the EU declaration of conformity is officially prepared.
CE Marking Benefits
Supplying products to the market with all legal requirements and CE marking will provide the following benefits to companies and consumers:
• Verifying and declaring that the product meets all technical, health, safety and environmental standards mentioned in EU directives and regulations adopted in our country by harmonization
• CE marking allows a product to circulate freely not only in the EU market, but also in the markets of many countries (including Turkey) that have accepted this procedure.
• The marked product can be easily recognized by consumers. This protects consumers from hazards that may arise due to product safety and health criteria being met.
• CE Certificate / mark gives manufacturers the opportunity to enter new markets.
• Companies that produce CE marked products can be granted privileges in public and private sector tenders.
• The corporate reputation of companies that make certified production increases. As a result of increasing customer satisfaction and decreasing complaints, it makes more sales and increases its competitiveness in the market.
• Firms with CE Certificate can benefit from government incentives much more easily and quickly.

CE Mark Consulting

Aşan Danışmanlık has many years of experience in CE Certificate / Mark / Label (CE Mark). Aşan Consulting, which has so far provided many companies with CE Certificates in different product categories, guides companies in all requirements and procedures related to CE marking. It professionally plans the whole process from the legal and technical affixing of the CE mark to the product without any problems. You can get support from Aşan Danışmanlık in all matters related to obtaining the CE mark; You can contact us on technical file preparation, product verification, notified bodies and many more.