CE Mark

Means the European Community and Conformité Européenné for other countries that adopt legislation.

Within the scope of the directives issued by the European Union Committees, it is aimed that the compliance of the products with the EU Directives and Standards on the health, safety and security issues and the free circulation of the products are made possible.

CE Marking is a sign that the EU is concerned with the products covered by the New Approach Directives and Regulations adopted in 1985 to ensure compliance with technical legislation and that the products comply with the basic requirements of the relevant EU directives and have undergone the necessary procedures.

These directives and regulations have been put into practice by our country since 2002.

NEW APPROACH DIRECTIVES WITH CE MARK / CERTIFICATE

• 90/396 / EC on Gas-fired Devices Regulation
• 2000/9 / EC Regulation on Wired Transport System Designed for Human Transport
• 89/106 / EC Building Materials Regulation
• 2004/108 / EC Electromagnetic Compatibility Regulation
• 94/9 / EC Implementing Regulation on Equipment and Protective Systems Used in Potentially Explosive Atmospheres
• 93/15 / EC Regulation on the Supply and Inspection of Explosive Materials for Civilian Use Markets
• 95/16 / EC Elevator Regulations
• 2006/95 / EC LVD Low Voltage Directive
• 2006/42 / EC Machinery Safety Regulation
• 2004/22 / EC Measuring Instruments Regulation
• 93/42 / EC Medical Devices Regulation
• 92/42 / EC Implementing Regulation on the Productivity Requirements of Liquid and Gas Fired Hot Water Boilers
• 90/384 / EC Non-Automatic Weighing Instruments Regulation
• 89/686 / EC Personal Protective Equipment Regulation
• 97/23 / EC Pressure Equipment Directive
• 1999/5 / EC on Radio and Telecommunication Terminal Equipment Directive
• 94/25 / EC Traveling Boat Regulation
• 87/404 / EC Simple Pressure Vessels Directives
• 2009/48 / EC Regulation on Toys

MODULES USED IN CE MARKING STUDIES

Modular Structure

A) Internal Control of Production

B) Type Examination

C) Type Compliance

D) Production Quality Assurance

E) Product Quality Assurance

F) Product Verification

G) Unit (Product) Verification

H) Full Quality Assurance

WHAT ARE THE BENEFITS OF CE MARKING?

• The CE Mark indicates that the product meets the health and safety requirements.
• The CE Mark opens the door to the free movement of merchandise from one country to another, which is a member of the European Community. In other words, a product covered by the New Approach Directives must have a CE Mark on it to enter any European Union country and possess a CE Certificate based on the product risk level. It is not possible to export products that are not required to be CE Mark and / or Certificate to EU Member States and other countries which have accepted legislation.
• The CE Mark acts as a kind of product passport.
• The CE mark indicates the level at which the qualification begins.
• CE Marking is a sign of conformity to the New Approach Directives.

WHO CAN USE CE MARKING / DOCUMENTATION?

Applicable to all products under the New Approach Directives mentioned above and to all establishments producing such products.

APPLICATION OF CE MARKING IN TURKEY

Under Article 8 of the Association Council Decision 1/95, which establishes the Customs Union between Turkey and the European Union, it is foreseen that Turkey will include in its internal legislation on elimination of technical barriers to trade.

In this framework, Turkish Public Institutions, which will harmonize community technical instruments with the Council of Ministers Decision dated 15.1.1997 and numbered 97/9196, have been identified.

Law No. 4703 on “Preparation and Implementation of Technical Legislation Related to Products” was published in the Official Gazette dated July 11, 2001 and numbered 24459 to ensure the legal infrastructure required for the effective application of the technical legislation to be adopted while the harmonization process was in progress and was enacted as of 11 January 2002 It was entered.

On the other hand, from the regulations of governing the procedures and principles of implementation of this law,

• Regulation on Conformity Assessment Establishments and Notified Establishments,
• Regulation on the Attachment and Use of the CE Marking to the Product,
• Regulation on Market Surveillance and Inspection of Products,
• Has been published in the Official Gazette dated January 17, 2002 and numbered 24643, and entered into force on 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 products bearing “New Approach Directives” in Turkey will have to be affixed to CE Mark since this date.
• The EU directives related to these products are covered by the “New Approach Directives” in Turkey without being put into force by the relevant organizations and they are not subject to the requirement of attaching the CE Mark in Turkey to the products offered to the internal market.
• Once regulatory compliance is complete, it will not be possible to supply products that do not bear this mark to the internal market.

HOW TO OBTAIN CE MARK / CERTIFICATE?

Any organization that wishes to obtain a CE Marking / Certificate for any product must first prepare a technical file of this product.

The technical file forms the basis of CE studies. A technical file is prepared if the company produces a device that does not enter the risk class and therefore uses its own CE Marking authority or produces a risky product and therefore has to be tested by a competent authority.

Low Risk Products: By issuing a declaration after making the manufacturer’s conformity assessment; the product is in compliance with the mandatory safety, health, environmental and consumer protection standards. It is necessary to be arranged in accordance with the norm of this declaration.

High Risk Products: Manufacturers declaration is not enough for these products. In this case, the products must be tested by a notified body. As a result of the inspection of the notified body, the manufacturer may place the CE mark on the product.