The CE marking on products indicates that these products comply with the essential requirements of the applicable directives in force and have been subject to the conformity assessment procedures specified in those directives. As EN Kalite Training and Consultancy, we also provide services during the Electronic Devices CE Certification process. The most fundamental step in CE marking is determining which directive or directives apply to the product. Several CE marking directives are commonly applied to electronic products. When trading electrical and electronic equipment on the European market, CE marking is mandatory for every company or organization if the equipment falls within the scope of the relevant CE directives. In general, the term electrical is used for all kinds of devices, operations and processes involving electric current. The term electronic is used to describe devices powered by electrical energy. A large number of electrical components are used in the manufacture of an electronic device. By affixing the CE marking to electronic equipment, the manufacturer or importer ensures that the product complies with applicable safety requirements. Electronic equipment bearing the CE marking may be freely bought and sold within the European Economic Area. Under the European Union’s New Approach program, implemented since 1985, product groups with certain characteristics were created and separate directives were issued for each group, thereby establishing the technical requirements for the products. One of these product groups consists of electrical and electronic devices. For these devices, the European Union issued the Electromagnetic Compatibility Directive (EMC) and the Low Voltage Directive (LVD). Under these legal regulations, the most fundamental obligations to be met by electronic devices are protection requirements.
The most commonly applied directives for electronic devices are as follows:
Devices must be designed and manufactured using state-of-the-art technology so as to meet the specified conditions. The magnetic disturbance generated must remain at a level that does not prevent the electronic device from operating as designed.
The immunity of the electronic device to electromagnetic disturbance arising during its own use must be at a level that allows it to operate without causing an irrecoverable loss of power.
Electromagnetic Compatibility Directive (EMC) No. 2014/35/EU: This directive covers almost all electronic devices. It explains criteria relating to radiated and conducted emissions performance and radiated and conducted immunity performance of electronic products.
Low Voltage Directive (LVD) No. 2014/35/EU: This directive applies to all electrical equipment designed for use with voltage ratings between 50 and 1000 volts for alternating current and between 75 and 1500 volts for direct current. Lower voltage limits have been removed for wireless devices. In this way, wireless devices must also be tested for safety.
Directive No. 2006/42/EC on the Restriction of the Use of Certain Hazardous Substances (ROHS): This directive regulates the maximum concentrations of hazardous substances contained in electronic products. An update made to this directive in 2013 ensured that many types of electronic equipment were brought into compliance with the rules. To ensure that electronic devices comply with the rules, it is necessary to make sure that components and manufacturing processes meet ROHS requirements.
Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE): This directive applies to all electronic and electrical devices. The directive aims to divert electrical and electronic equipment from waste-disposal sites to recycling facilities. Manufacturers are required to mark these products with the WEEE logo and provide information concerning matters such as product sales. Manufacturers outside the European Union are also required to participate in recycling activities.
The manufacturer must identify and apply the directives that are applicable to its product among these different directives. If an electronic product passes all tests specified in the relevant harmonized standards, it is presumed to comply with the requirements of the applicable directives. In addition, electronic waste may not simply be disposed of in ordinary waste bins and must therefore comply with certain environmental substance and waste directives. Under the relevant directives, assessment of the product’s conformity with the essential obligations is left to the manufacturer. The manufacturer demonstrates that the necessary conditions have been met through the technical file and written declaration of conformity it prepares. However, if the manufacturer wishes, it may also apply to a notified body and request a certificate demonstrating that the essential requirements have been met. As a result, electronic equipment that meets the necessary requirements is affixed with the CE marking by the manufacturer and placed on the market. Products placed on the market improperly may be withdrawn from the market and may also be subject to penalties.
The conformity procedure may be divided into the following sections:
- Testing in accordance with electronic-device standards
- Preparing procedures to ensure conformity of serial production
- Providing identification elements for the product and the economic operator
- Providing instructions (user manual) and safety information
- Developing procedures for taking corrective action
- Preparing technical files through which product conformity can be assessed
- Preparing the EU Declaration of Conformity and declaring that the product complies with the directive and harmonized standards
- Affixing the CE marking in accordance with the Electronic Devices Directive
“Electronic Devices CE Certification is only one of the services provided by EN Kalite Training and Consultancy. Many other certification services are also provided. Through these services, businesses can carry out safer, more efficient, higher-performance and higher-quality production.“
