WHAT IS THE CE MARK?
The CE Mark comes from the initials of the French words "Conformité Européenne", meaning “European Conformity.” The CE Mark is a health and safety mark implemented within the framework of the “New Approach” established by the European Union in 1985 to enable the free movement of goods.
The CE Mark indicates that a product or product group complies with the essential requirements—known as product directives—established by the European Union in the fields of Health, Safety, Environment, and Consumer Protection. Product directives determine what essential requirements a product must meet and/or the level of performance it must achieve.
The legislation implemented in 1985 initially used the term “EC Mark,” but this was officially changed to “CE Marking” with Directive 93/68/EEC published in 1993. Today, it is referred to as CE Marking in all European Union countries.
The CE Mark is an indication that a product can legally be placed on the market in the relevant region. It also signifies that, in the event of any non-compliance, the manufacturer will unconditionally withdraw the product from the market. The CE Mark is not a quality mark; rather, it shows that the product has been manufactured and inspected in accordance with all the requirements set forth by the relevant directives.
The conformity processes for product groups defined for CE are carried out by the relevant ministries, other public institutions, and the Undersecretariat for Foreign Trade, depending on the product category.
From a foreign trade perspective, it is not possible to export any product falling within the scope of one or more of the currently 25 New Approach Directives to European Union member states without the CE Mark. From a domestic market perspective, legislative alignment has been completed, and mandatory implementation has taken effect. Products that fall under the relevant product regulations and are required to bear the CE Mark cannot be placed on the Turkish market without it.
The “CE” conformity marking consists of the initials “CE” in the following form:
BENEFITS OF THE CE MARK
The CE Mark ensures the free movement and marketing of products within EU countries.
Manufacturers are obliged to affix the “CE” mark on their products in order to market them at both national and international levels.
The CE Mark indicates that the product complies with EU technical legislation.
The CE Mark serves as a type of product passport.
The CE Mark is absolutely not a quality mark or a guarantee certificate.
The CE Mark indicates the minimum level at which quality begins.
Products below this level are considered unsafe and cannot be placed on the market; therefore, they are deemed to be of poor quality.
A product bearing the CE Mark cannot be rejected in EU countries on legal grounds related to standards.
The CE Mark is an indication of compliance with the New Approach directives.
Therefore, the CE Certificate (Mark) also serves as a “Passport” for products manufactured outside the EU.
What Happens If the CE Mark (Certificate) Is Missing?
For all products within the 23 product groups for which the CE Mark (certificate) is mandatory, export to the EU without the CE Mark (certificate) is not possible. In Turkey, according to recent legal amendments, it has become mandatory for such products to bear the CE Mark (certificate). Over time, this requirement will be applied to all products for which CE marking is compulsory.
Unlawful Use of the CE Mark
If it is determined that the CE Mark has been affixed unlawfully or has not been affixed at all, the manufacturer or authorized representative is obliged to cease the violation under the conditions set by the Ministry.
If the violation continues, the Ministry shall take all necessary measures to restrict or prohibit the placing of the product on the market and ensure its withdrawal from the market.
MEDICAL DEVICES REGULATION
The purpose of this Regulation is to establish the essential requirements for medical devices and accessories, and to regulate the procedures and principles regarding their design, classification, manufacture, placing on the market, making available on the market, and inspection, in order to ensure protection against potential hazards to the health and safety of patients, operators, users, and third parties during their use.
This Regulation covers all activities of public institutions and organizations, as well as natural and legal persons, related to the design, manufacture, placing on the market, making available on the market, use, and inspection of medical devices and accessories.
If a device is manufactured for the purpose of administering a medicinal product that falls within the scope of the Regulation on Licensing of Human Medicinal Products published in the Official Gazette No. 25705 dated 19.01.2005, such device shall be evaluated within the scope of this Regulation. This does not prevent the application of the provisions of the Regulation on Licensing of Human Medicinal Products to the medicinal product.
If a device is placed on the market in combination with a medicinal product as a single product and is intended for single use, that single product shall be subject to the provisions of the Regulation on Licensing of Human Medicinal Products. In this case, where matters relating to the safety and performance of the medical device are concerned, the provisions set out in Annex I of this Regulation on essential requirements shall apply.
If a device is intended to be used in conjunction with a substance for the purpose of assisting its function on the human body, and if this substance, when used independently of the device, is considered a medicinal product under the Regulation on Licensing of Human Medicinal Products, such device shall be evaluated within the scope of this Regulation.
If a device is intended to be used in conjunction with a substance for the purpose of assisting its function on the human body, and if this substance, when used independently of the device, is considered a medicinal product derived from human blood or plasma (human blood derivative) under the Regulation on Licensing of Human Medicinal Products, such device shall be evaluated within the scope of this Regulation.
This Regulation shall not apply to:
a) In vitro diagnostic medical devices,
b) Active implantable medical devices falling within the scope of the Regulation on Active Implantable Medical Devices published in the Official Gazette No. 26398 dated 09.01.2007,
c) Medicinal products falling within the scope of the Regulation on Licensing of Human Medicinal Products published in the Official Gazette No. 25705 dated 19.01.2005,
d) Cosmetic products falling within the scope of the Cosmetics Law No. 5324 dated 24.03.2005,
e) With the exception of human blood derivatives; human blood, blood products, plasma or blood cells of human origin, human cells, tissues, transplant organs, or products manufactured from them,
f) Animal tissues and animal cells, except for medical devices containing non-viable animal tissues or products manufactured from such tissues.
In deciding whether a product falls within the scope of the Regulation on Licensing of Human Medicinal Products or this Regulation, the primary function of the product shall be taken into account.
If a device is intended by the manufacturer to be used in compliance with both this Regulation and the Regulation on Personal Protective Equipment published in the Official Gazette No. 26361 dated 29.11.2006, the essential health and safety requirements of both regulations shall be fulfilled.
For devices subject to conformity assessment under this Regulation, the provisions of the Electromagnetic Compatibility Regulation published in the Official Gazette No. 26680 dated 24.10.2007 shall not apply.
The provisions of this Regulation shall not affect the application of regulations relating to radiation safety and medical exposure.
2014/33/EU LIFT DIRECTIVE
Purpose:
The purpose of this Regulation is to determine the essential health and safety requirements that lifts and lift safety components must meet, as well as the conditions for placing these products on the market and the principles of market surveillance and inspection.
Scope:
This Regulation covers:
a) Lifts permanently used in buildings and constructions, and the safety components listed in Annex IV of this Regulation to be used in such lifts,
b) (Amended: OG – 14/8/2009 / 27319) Lifts that move over a fixed distance even if they do not move along fixed rails.
(Amended: OG – 14/8/2009 / 27319) This Regulation does not cover:
a) Lifting appliances with a speed of 0.15 m/s or less,
b) Lifts used on construction sites,
c) Cableway installations, including cable-hauled vehicles on a railway line,
d) Lifts specially designed and constructed for military or police purposes,
e) Lifting appliances from which work can be carried out,
f) Mine lifts,
g) Lifting appliances intended for lifting artists during artistic performances,
h) Lifting appliances installed on vehicles,
i) Lifting appliances connected to machines and intended solely for access to workstations, including maintenance and inspection points on the machine,
j) Rack and pinion trains,
k) Escalators and moving walkways.
Legal Basis:
This Regulation has been prepared based on the Law No. 4703 on the Preparation and Implementation of Technical Legislation Regarding Products dated 29/6/2001.
It has been prepared within the framework of harmonization with European Union legislation, based on Directive 2014/33/EU of the European Parliament and of the Council of 26/2/2014 on the harmonization of the laws of Member States relating to lifts and safety components for lifts.
Definitions:
a) EU: European Union,
b) Accreditation: The formal recognition by the national accreditation body that a conformity assessment body meets the requirements set by the relevant harmonized standards and, where applicable, additional requirements set out in the relevant sectoral regulations, to carry out a specific conformity assessment activity,
c) Lift: A lifting appliance serving specific levels, having a carrier moving along rigid guides inclined at an angle of more than 15 degrees to the horizontal, or a lifting appliance moving along a fixed course even if not along rigid guides,
ç) Lift installer: The natural or legal person responsible for the design, manufacture, installation, and placing on the market of the lift,
d) Ministry: Ministry of Science, Industry, and Technology,
e) “CE” marking: The marking affixed by the lift installer or manufacturer indicating that the lift or lift safety component complies with the essential health and safety requirements of this Regulation,
f) Distributor: Any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a lift safety component available on the market,
g) Recall: Any measure aimed at dismantling the lift and disposing of it safely, or returning lift safety components already supplied to the lift installer or end-user,
ğ) Economic operator: Lift installer, manufacturer, authorized representative, importer, and distributor,
h) Manufacturer: Any natural or legal person who manufactures a lift safety component under their name or trademark, or has a lift safety component designed or manufactured and markets it,
ı) Importer: Any natural or legal person established in Türkiye who places a lift safety component imported from abroad on the market,
i) Commission: European Commission,
j) Model lift: A representative lift, defined according to objective parameters, that meets the essential health and safety requirements in Annex I and uses lift safety components in compliance with the model shown in its technical file,
k) Placing on the market: The first making available of a lift safety component on the market or making a lift available for use, whether for payment or free of charge, in the course of commercial or public activities,
l) Making available on the market: Any supply of a lift safety component for distribution or use on the market in the course of a commercial activity, whether for payment or free of charge,
m) Withdrawal: Any measure aimed at preventing a lift safety component in the supply chain from being made available on the market,
n) Carrier: The part of the lift designed to accommodate persons and/or goods to be lifted or lowered,
o) Technical specification: A document defining the technical requirements to be met by a lift or lift safety component,
ö) TÜRKAK: Turkish Accreditation Agency,
p) Conformity assessment: The process of demonstrating whether a lift or lift safety component within the scope of this Regulation meets the essential health and safety requirements,
r) Conformity assessment body: A body that performs conformity assessment activities, including calibration, testing, inspection, and certification,
s) Harmonized standard: A European standard adopted on the basis of a request made by the Commission to apply harmonized European Union legislation,
ş) Member State: A Member State of the European Union,
t) Authorized representative: Any natural or legal person established in Türkiye who has received a written mandate from the manufacturer or lift installer to perform certain tasks on their behalf.
LOW VOLTAGE DIRECTIVE
Directive 2014/35/EU – Low Voltage Regulation
Purpose:
The purpose of this Regulation is to establish the procedures and principles related to the safety rules and conformity assessment procedures required for the placing on the market of electrical equipment within the scope of this Regulation, after meeting the safety requirements and conformity assessment procedures set out herein.
Scope:
This Regulation covers electrical equipment designed for use with a rated voltage between 50 volts and 1000 volts for alternating current, and between 75 volts and 1500 volts for direct current.
The equipment and situations specified in Annex II of this Regulation are excluded from its scope.
CE Conformity Marking:
The principles for the use and affixing of the CE conformity marking to electrical equipment are as follows:
Before being placed on the market, the conformity assessment procedures specified in Annex IV shall be followed for electrical equipment within the scope of this Regulation.
A Declaration of Conformity, in the form and under the conditions set out in Annex III, shall be prepared to declare that the equipment complies with the provisions of this Regulation.
The CE conformity marking shall be affixed to the equipment in accordance with the principles set out in subparagraph (c) of this article.
In the event of an objection or suspicion, the manufacturer or importer may submit a report issued by a notified body, in accordance with the procedure specified in subparagraph (d) of Article 13, confirming that the electrical equipment complies with this Regulation.
The CE conformity marking, the sample of which is given in Annex III, shall be affixed visibly, legibly, and indelibly by the manufacturer or their authorized representative established in Türkiye, to the electrical equipment itself, or where this is not possible, to its packaging, user manual, or warranty certificate.
No other markings or inscriptions that may mislead third parties regarding the meaning or form of the CE marking may be affixed to the electrical equipment.
However, other markings indicating compliance with national or international standards or other regulations may be affixed to the product, its packaging, user manual, or warranty certificate, provided they do not impair the visibility or legibility of the CE marking.
If the electrical equipment is also subject to other regulations that require the affixing of the CE marking, the CE marking shall indicate that the equipment complies with the provisions of those regulations as well.
However, if one or more of these regulations allow the manufacturer to choose which to apply during a transitional period, the CE marking shall indicate compliance only with the regulation(s) applied by the manufacturer.
In such cases, the details and provisions of the applied regulation(s) shall be provided in the documents, notices, and manuals accompanying the electrical equipment, as stipulated in the regulations.
Published in the Official Gazette dated 02.10.2016, No. 29845
Article 1 – Purpose:
The purpose of this Regulation is to determine the procedures and principles ensuring that electrical equipment on the market meets requirements that provide a high level of protection for the health and safety of persons, domestic animals, and property, while ensuring the functioning of the internal market.
Article 2 – Scope:
This Regulation covers electrical equipment designed for use with a voltage rating between 50 V and 1000 V for alternating current and between 75 V and 1500 V for direct current, excluding the equipment and situations listed in Annex II.
Article 3 – Legal Basis:
This Regulation is prepared based on the Law No. 4703 on the Preparation and Implementation of Technical Legislation Regarding Products, dated 29/6/2001.
Article 4 – Definitions:
In this Regulation:
a) Ministry: Ministry of Science, Industry and Technology,
b) CE marking: The marking affixed by the manufacturer to indicate that the electrical equipment complies with the requirements set out in the relevant technical legislation requiring the affixing of the CE marking,
c) Distributor: Any natural or legal person in the supply chain, other than the manufacturer or importer, who makes electrical equipment available on the market,
ç) Recall: Any measure aimed at returning electrical equipment already in the possession of the end user to the economic operator,
d) Economic operators: Manufacturer, authorized representative, importer, and distributor,
e) Manufacturer: Any natural or legal person who manufactures electrical equipment or has it designed or manufactured, and markets it under their name or trademark,
f) Importer: Any natural or legal person established in Türkiye who imports a product from abroad and places it on the market,
g) Making available on the market: Any supply of electrical equipment for distribution, consumption, or use on the market in the course of a commercial activity, whether for payment or free of charge,
ğ) Withdrawal: Any measure aimed at preventing electrical equipment in the supply chain from being made available on the market,
h) Placing on the market: The first making available of electrical equipment on the market,
ı) Technical specification: A document defining the technical requirements to be met by electrical equipment,
i) Conformity assessment: The process demonstrating whether the electrical equipment meets the safety requirements set out in Article 5 and explained in Annex I,
j) Harmonized standard: A European standard adopted based on a request made by the European Commission to apply harmonized European Union legislation,
k) Member States: Member States of the European Union,
l) Authorized representative: Any natural or legal person established in Türkiye who has received a written mandate from the manufacturer to perform certain tasks on their behalf.
Directive 2014/68/EU – Pressure Vessels Regulation
(1) Purpose:
The purpose of this Regulation is to establish the procedures and principles related to the design, manufacture, and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure (PS) greater than 0.5 bar.
Scope:
This Regulation covers pressure equipment with a maximum allowable pressure (PS) greater than 0.5 bar.
(2) This Regulation does not cover the following:
a) Pipelines consisting of a pipe or piping system designed for the conveyance of any fluid or substance to a facility or from an onshore or offshore facility, including all attached equipment, up to the last isolation device within the facility, excluding standard pressure equipment located in pressure reduction or compression stations,
b) Networks and related equipment for the supply, distribution, and discharge of water, including pressurized water transport pipes, pressure tunnels, pressure shafts for hydroelectric installations, and associated special accessories,
c) Equipment covered by the Simple Pressure Vessels Regulation published in the Official Gazette dated 30/12/2006 and numbered 26392 (87/404/EEC),
ç) Equipment covered by the Aerosol Dispensers Regulation published in the Official Gazette dated 30/11/2000 and numbered 24246 (75/324/EEC),
d) Equipment defined for vehicle functions by the legislation and annexes listed below:
Motor Vehicles and Trailers Type Approval Regulation (70/156/EEC) – Official Gazette dated 1/4/1999 and numbered 23653,
Wheeled Agricultural or Forestry Tractors Type Approval Regulation (74/150/EEC) – Official Gazette dated 7/1/1999 and numbered 23576,
Two- or Three-Wheeled Motor Vehicles Type Approval Regulation (2002/24/EC) – Official Gazette dated 23/12/2004 and numbered 25679,
e) Equipment classified as no higher than Category I as described in Article 10 of this Regulation, which is covered by the following:
Machinery Safety Regulation (98/37/EC) – Official Gazette dated 30/12/2006 and numbered 26392,
Lifts Regulation (95/16/EC) – Official Gazette dated 15/2/2003 and numbered 25021,
Low Voltage Electrical Equipment Regulation (73/23/EEC) – Official Gazette dated 30/12/2006 and numbered 26392,
Medical Devices Regulation (93/42/EEC) – Official Gazette dated 13/3/2002 and numbered 24694,
Gas Appliances Regulation (90/396/EEC) – Official Gazette dated 30/12/2006 and numbered 26392,
Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulation (94/9/EC) – Official Gazette dated 30/12/2006 and numbered 26392,
f) Military equipment covered by Article 223(1)(b) of the Treaty of Rome establishing the European Community,
g) Equipment specifically designed for nuclear use, the failure of which may cause the emission of radioactivity,
h) Well-control equipment used in petroleum, gas, or geothermal exploration and drilling industries and in underground storage, including wellheads, blowout preventers, pipe manifolds, and all associated equipment,
i) Equipment where pressure is not a significant design factor, having adequate strength, stiffness, or stability to withstand static or dynamic functional effects or other operational effects, and which are designed, dimensioned, and manufactured accordingly, including:
Engines, including turbines and internal combustion engines,
Steam engines, gas/steam turbines, turbo generators, compressors, pumps, and actuating devices,
Blast furnaces, including cooling systems, hot air recuperators, dust extractors, and hot furnace exhaust gas cleaners,
Melting, remelting, degassing furnaces, including casting ladles for steel and non-ferrous metals,
Enclosures for high-voltage equipment such as circuit breakers and transformers, and for rotating machines,
Pressure pipes for the protection of transmission systems (e.g., electric and telephone cables),
Equipment designed for use on ships, rockets, aircraft, mobile offshore units, and vessels or for their propulsion,
Pressure equipment consisting of flexible enclosures such as vehicle tyres, airbags, balls, inflatable boats, and similar,
Exhaust and intake silencers,
Vessels designed for the distribution and transport of beverages where the PS × V value does not exceed 500 bar·L and the maximum allowable pressure does not exceed 7 bar,
Equipment covered by the ADR, RID, IMDG, and ICAO agreements on the international transport of dangerous goods,
Bottles and cans for carbonated beverages intended for final consumption,
Radiators and pipes in hot water heating systems,
Vessels designed for the storage of liquids where the gas pressure above the liquid does not exceed 0.5 bar.
89/686/EEC – Personal Protective Equipment (PPE) Regulation
Purpose:
The purpose of this Regulation is to set forth the procedures and principles regarding the manufacture, import, placing on the market, making available, and inspection of personal protective equipment used to protect human health and safety, as well as the protection of the life and property of third parties against hazards.
Scope:
This Regulation covers the procedures and principles to be followed by public institutions and organizations, as well as natural and legal persons, in relation to the manufacture, import, placing on the market, making available, and inspection of personal protective equipment.
Personal protective equipment (PPE) that falls under the scope of another regulation issued for the same purposes of free movement of goods and safety, and which is listed in Annex 1, is excluded from the scope of this Regulation.
PPE placed on the market must meet the essential health and safety requirements specified in Annex 2 and, when used as intended, must not endanger the health and safety of users, other persons, animals, or property.
The placing on the market of PPE or PPE components bearing the CE conformity marking, demonstrating compliance with all provisions of this Regulation — including the certification procedures described in Parts Three, Four, Five, Six, Seven, and Eight — cannot be prohibited, restricted, or hindered.
The placing on the market of PPE components intended to be used together with PPE, which do not bear the CE marking, cannot be prevented, provided they are not an essential part of the PPE
PPE that does not comply with the provisions of this Regulation cannot be used and/or sold for any purpose unless it carries a clear marking indicating such non-compliance and that it will not be made compliant by the manufacturer or the authorized representative established in Turkey. Such PPE cannot be promoted or displayed at fairs or exhibitions without such a marking.
2009/48/EC – Toy Safety Regulation
Purpose:
The purpose of this Regulation is to establish the procedures and principles regarding the essential requirements to be fulfilled for toy safety, their placing on the market, distribution, and market surveillance and inspection.
Placing Toys on the Market:
Placing on the market means the activity of making a toy available on the market, whether for payment or free of charge, for the purpose of supply or use.
Toys manufactured taking into account the normal behavior of children, and which, when used as intended or in a foreseeable way, do not endanger the safety and/or health of users or third parties, may be placed on the market.
A toy placed on the market must meet the essential requirements specified in this Regulation, considering its intended use and expected duration of use.
The placing on the market of toys that comply with the provisions of this Regulation cannot be prohibited.
Compliance of Toys:
Article 6 – Toys bearing the CE marking as required by Article 9 of the Regulation shall be deemed to comply with the provisions of this Regulation, including the conformity assessment procedures.
A toy manufactured in compliance with harmonized national standards relating to toys within the scope of this Regulation shall be deemed to meet the essential requirements set out in Annex II.
If the manufacturer does not apply the harmonized national standards, applies only certain parts of them, or if no such harmonized national standard exists, the toy shall be considered to meet the essential requirements set out in Annex II once it bears the CE marking indicating compliance with the approved type after obtaining the EC Type Examination Certificate.
If toys fall under the scope of other legislation requiring the affixing of the CE marking, they must comply with both this Regulation and the relevant provisions of such other legislation.
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