CE Marking Regulatıon

“CE” MARKING REGULATION

FIRST PART

Purpose, Scope, Basis and Definitions

ARTICLE 1- (1) The purpose of this Regulation; It is to determine the procedures and principles regarding the placing of the "CE" mark on the product and the use of this mark.

Scope

ARTICLE 2- (1) This Regulation covers the products for which the "CE" mark is foreseen to be placed on the product in the relevant technical regulation.

Rest

ARTICLE 3- (1) This Regulation has been prepared based on subparagraph (a) of the second paragraph of Article 24 of the Product Safety and Technical Regulations Law dated 5/3/2020 and numbered 7223.

Definitions and abbreviations

ARTICLE 4- (l) In this Regulation;

a) EU: The European Union, the mark showing that it complies with all the relevant rules of the technical legislation that prescribes the CE marking,

c) Distributor: The real or corporate person, other than manufacturing or importing, who makes the product available on the market by being in the supply chain,

p) Manufacturer: The natural or legal person who manufactures the product or has the product designed or manufactured and puts it on the market under its own name or trademark,

d) Importer: The natural or legal person residing in Turkey who imports the product and puts it on the market,

e) Commission: European Commission,

f) Module: each of the ways that shows which conformity assessment processes will be subjected to thin according to the relevant technical arrangement, and according to the risks the product carries,

g) Notified body: The conformity assessment body appointed by the authorized institution of Turkey or an EU member country in accordance with the principles set forth in the relevant legislation to carry out conformity assessment activities within the scope of a technical regulation and notified to the Commission,

ğ) Pictogram: The figure on the product that depicts a feature related to the product,

h) Placing on the market: Providing the product to the market for distribution, consumption or use, with or without charge, through commercial activity,

i) Placing on the market: The first placing of a product on the market,

i) Standard: One of the following technical requirements, which are accepted for repeated or continuous use by a recognized standardization body, and which are not mandatory for compliance;

1) International standards accepted by an international standardization organization,

2) European standards accepted by a European standardization body,

3) European standards adopted upon the request of the Commission for the implementation of EU harmonization legislation,

4) National standards accepted by the national standardization body,

j) Technical regulation: The mandatory legislation that determines the quality of the product, its processing or production methods, or the related terminology, symbols, packaging, marking, labeling or conformity assessment forms, individually or in combination with administrative provisions, and which must be complied with,

k) Technical Wrapping: The document that determines the technical conditions that a product, process or service must meet,

1) Conformity assessment: The process showing whether certain conditions regarding the product, process, service, system, person or organization are fulfilled,

m) Conformity assessment body: the organization that performs conformity assessment activities, including calibration, testing, certification and inspection,

n) Conformity mark: It means that the product is in conformity with the relevant technical regulation.

sign,

o) Harmonized standard: In order for the EU harmonization legislation to be implemented, the Commission must

the standard adopted upon request,

o) Authorized institution: The public institution that prepares and executes the technical regulations regarding the products or inspects the products,

p) Authorized representative: The real or legal person residing in Turkey, appointed in writing by the manufacturer to fulfill some of the obligations of the manufacturer under the Law no. 7223 and other relevant legislation on his behalf,

means.

SECOND PART

Obligations of the Parties

Obligations of the manufacturer

ARTICLE 5- (1) The manufacturer, without prejudice to other obligations determined in the relevant technical regulation;

a) To prepare the technical file required by the relevant technical regulation,

b) To carry out and/or have the conformity assessment procedures done,

c) issuing the EU declaration of conformity or other documents showing conformity,

9) By placing the "CE" mark on the product,

d) To keep the technical file and the EU declaration of conformity for the period specified in the relevant technical regulation, for ten years from the date the product is placed on the market in cases where the time is not specified, and to present it to the authorized institution in Turkish or in a language acceptable to the authorized institution, if requested,

responsible..

Obligations of the authorized representative,

ARTICLE 6- (1) The authorized representative, without prejudice to other obligations specified in the relevant technical regulation;

a) If the manufacturer assigns himself in writing, to carry out the conformity assessment procedures for the product or to have it done,

b) To issue the EU declaration of conformity or other documents showing its conformity, unless otherwise stated in the relevant technical regulation,

c) Even if it puts the "CE" mark on the product, it cannot issue a technical file.

(2) In the assignment document, the minimum authorized representative will keep the documents required by the technical regulation and showing the conformity of the product for the period specified in the technical regulation, for at least ten years from the date the product is placed on the market in cases where the time is not specified, and that Turkish or the authorized organization accepts the documents upon the request of the authorized institution. It is stated that it will provide it in another language.

Obligations of the importer

ARTICLE 7- (1) Imports, without prejudice to other liabilities determined in the relevant technical arrangement;

a) Confirming that the manufacturer has fulfilled its obligations in Article 5,

b) Confirming that the product carries the "CE" mark and that the product is accompanied by the necessary documents,

c) Keeping a copy of the EU declaration of conformity for the period specified in the technical regulation, in Turkish for ten years from the date of placing the product on the market or in a language accepted by the authorized institution, to the authorized institution for a period of ten years from the date of placing the product on the market, for a period of ten years from the date of placing the product on the market in Turkish or is obliged to provide it to the authorized institution in a language accepted by the authorized institution.

Distributor´s obligations,

ARTICLE 8- (1) The distributor takes the necessary care while keeping the product on the market. The distributor submits the information and documents to the authorized institution, provided that the other obligations determined in the relevant technical regulation are preserved.

THIRD PART

Placing, Using the CE Mark on the Product and EU Declaration of Conformity

Placing and using the “CE” mark on the product

ARTICLE 10- (1) By placing or ensuring that the "CE" mark is placed on the product, the product is deemed to have declared that it is under its own responsibility to comply with the relevant technical arrangement or regulations that foresee the placing of this mark, and that the product has been subjected to all necessary conformity assessment processes.

b) In case a product is subject to more than one technical regulation requiring the "CE" mark to be placed, the "CE" mark on the product constitutes that the applicable provisions of all relevant technical regulations have been fulfilled by the manufacturer. However, in cases where one or more technical regulations give the manufacturer a choice to apply during a transitional period, the "CE" mark only indicates compliance with the provisions of the applied technical regulation or regulations.

c) “CE” mark;

1) The bit consists of the letters “CE” in accordance with the shape specified in the annex of the Regulation (ANNEX-1 “SHAPE OF “CE” MARKING) and the design of the sign cannot be changed, except by reducing and enlarging it in accordance with the proportions in the drawing.

2) Unless otherwise specified in the relevant technical arrangement, it shall be at least 5 mm in size.

3) It is placed in the product or on the information plate, or in cases where this is not possible due to the nature of the product or its permanence cannot be guaranteed, in its packaging and in the documents accompanying the product as stipulated by the relevant technical regulation, in a visible, legible and indelible manner.

4) The product is put on the market before it is placed on the market.

5) It is placed only by the manufacturer or his authorized representative,

p) In cases required by the relevant technical regulation, the identification registration number of the notified body involved in the production control phase is placed next to the “CL” mark. The identification registration number is placed by the notified body itself or by the manufacturer or the manufacturer´s authorized representative in accordance with the organization´s instructions. In the event that a product is subject to the evaluation of more than one approved organization due to the fact that it is within the scope of different technical regulations, the identification registration numbers of the trim approved organizations in the production control phase are located next to the “CE” mark.

d) Along with the “CE” mark, pictograms or other signs describing a particular risk or use may be included on the product.

e) No other signs or descriptions that will mislead third parties about the meaning and form of the "CE" mark can be placed on the urine. Any other mark may be placed on the product only in a way that does not impair the visibility, legibility and meaning of the "CE" mark.

f) The “CE” mark can only be used on products for which technical regulations are required and cannot be used on other products.

g) When required by the relevant technical regulations, the "CE" mark is placed in such a way that it can be read by the visually impaired.

EU declaration of conformity

ARTICLE 1t- (1) If the EU declaration of conformity is stipulated in the relevant technical regulation, it is drawn up by the manufacturer or its authorized representative to notify that the product complies with the requirements of the technical regulation.

(2) The EU declaration of conformity is prepared in accordance with the ongoid of the relevant module or modules at least, unless otherwise specified in the relevant technical regulation, and in accordance with the annex to this Regulation (ANNEX-2 EU DECLARATION OF CONFORMITY SAMPLE). In cases where it is issued in other languages, a Turkish translation is also attached to the declaration. The statement is updated whenever necessary.

(3) In older states where the product is subject to more than one technical regulation requiring an EU declaration of conformity, the manufacturing business shall demonstrate by issuing a single EU declaration of conformity that these technical regulations fulfill the trim rules applicable to the product. The text of the declaration includes the name, issue date and reference number of these technical regulations.

(4) Once the manufacturer has drawn up and signed the EU declaration of conformity, it is assumed that the product has assumed responsibility for compliance with the rules of the relevant technical regulation.

(5) EU declaration of conformity can also be submitted electronically, if the competent authority accepts it.

Other declarations of conformity

ARTICLE 12- (1) If a declaration of conformity other than the EU declaration of conformity is foreseen in the relevant technical regulation to show the conformity of the product with the requirements of the technical arrangement, the declaration of conformity is drawn up in accordance with the procedures and principles specified in the relevant technical arrangement.

CHAPTER FOUR

Equivalence of authorized representatives residing in EU member states

ARTICLE 13- (1) Authorized representatives residing in EU member countries are considered equivalent to authorized representatives residing in Turkey on the basis of reciprocity.

Application

ARTICLE 14- (1) The provisions of this Regulation are applied together with the technical regulations that require the "CE" mark to be placed on the reverse.

Administrative sanctions

ARTICLE 15- (1) The provisions of Law No. 7223 are applied to those who act against the provisions of this Regulation.

European Union legislation

ARTICLE 16- (1) This Directorate is on the “Consultation of the European Parliament and Council No. (EU) 765/2008 of 9/7/2008 on the Knowledge of Accreditation and the Rules of Market Surveillance and Supervision” and “On the General 9erpeve Regarding the Placing of Products on the Market”. It has been prepared within the framework of harmonization with the European Union legislation on the basis of the "Decision of the European Parliament and the Council (EU) 768/2008 dated /7/2008".

References in repealed regulation and legislation

ARTICLE 17- (1) The “CE” Marking Regulation, which was put into effect with the Council of Ministers Decision dated 16/12/2011 and numbered 2011/2588, has been repealed.

(2) In the legislation, omissions made to the "CE" Aftermarket Regulation, which is abolished with the first paragraph, shall be deemed to have been made to this Regulation.

Enforcement

ARTICLE 18- (1) This Regulation enters into force on the date of its publication.

Executive

ARTICLE 19- (1) The provisions of this Regulation are made by the President of the Republic.

CE Marking Regulatıon

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