ce marking and certification in the European Union

 

GENERAL INFORMATION

Many manufacturers come to the need to increase sales through the development of foreign markets, where the availability of international certificates for products are must for its delivery and sale!
 
CE certificate (Conformitée Européenne) - in translation from French "European conformity". This is a document confirming the products compliance with the European Union requirements. Its availability allows you to export products to any country in the European Union freely. It also facilitates the procedure for issuing a certificate of conformity within the legislation of any state that enters EU. In addition, the European quality certificate makes it possible to install CE marking on products, which legitimizes the unhindered circulation of products in the foreign market.
 
The CE certification history has its origins since the formation of a common European economic space and begins in 1985. The first EU Directives were approved and adopted with the aim of creating a unified technical requirements database for safety and quality of products entering the EU market.
 
 In addition to mandatory application in European countries, CE certification is in demand in Asia, North and South America on a voluntary basis. As for the European Union, then any product must be certified for compliance with the euro-norms and euro-directives requirements (the chemical, pharmaceutical and food products is not marked by "CE" sign).
 
CE certification is a way of official confirmation that all basic safety requirements for people, animals, the environment and property have been met in the production.
 
It should be noted that in the CE-certification system, the fulfillment of security requirements for the priority of implementation is higher than the quality requirements.
 
The standards of the CE certificates are prescribed in the legislative documents - the European Union Directives. To protect the customer from additional risks, other types of voluntary markings can be used, which supplement the CE certification.
 
Now the CE certificate is mandatory for 24 types of goods: building materials, construction products, personal protective equipment, elevators, medical devices and equipment, explosion-proof equipment and others. Any children's products are subjected to especially strict control.
The CE marking is placed on all products (except for chemical, pharmaceutical and food products). Moreover, if this is not possible, this symbol is applied to the packaging.
 

RULES AND CONDITIONS FOR THE APPLICATION OF CE MARKING

The CE marking is applied to the product or to the technical data plate in such a way that it is clearly visible, legible and indelible. If the product characteristics do not allow this, or it is not justified, it should be applied to the packaging and accompanying documentation, if the current legislation provides for these documents.
 
The CE marking is applied before the product export. Next to the marking, an icon or any other sign that indicates a hazard or a particular method of use may be stamped.
 
The CE designation should be followed by the identification number of the notified body, if the specified body participates in the production control phase and this is determined by one of the certification modules. The notified body identification number shall be submitted by the body itself or at its direction by the manufacturer or authorized representative.
 
The European Union Member States shall ensure the proper application of the mechanism governing the CE marking and take the necessary measures in case of abuse of marking. In addition, Member States impose sanctions for violations that may include criminal penalties for serious violations. These sanctions should be commensurate with the seriousness of the violation and constitute an effective means of motivation against misuse.
 
It is assumed that through the products certification in accordance with the standards adopted by CEN (European Committee for Standardization), CENELEC (European Committee for Electro technical Standardization) or ETSI (European Telecommunications Standards Institute)  the manufacturer demonstrates that it comply with the basic security requirements.
 

LIST OF EUROPEAN UNION DIRECTIVES FOR CE-CERTIFICATION

  • 2006/42/EC Machinery;
  • 2014/34/EU (ATEX) Equipment and protective systems for use in potentially explosive atmospheres;
  • 2014/30/EU Electromagnetic compatibility;
  • 2000/14/EC Noise emission in the environment by equipment for use outdoors – applies to 206/42/EC, applies to certain machines that can not be marked with CE marking without noise compliance;
  • 89/686/EEC Personal protective equipment;
  • 90/385/EEC Active implantable medical devices;
  • 92/42/EEC Requirements for the effectiveness of new hot-water boilers with liquid or gaseous fuels - Hot-water boilers;
  • 93/42/EEC Medical devices;
  • 94/25/EC Recreational craft;
  • 98/79/EC In vitro diagnostic medical devices;
  • 99/5/EC Radio and telecommunications terminal equipment;
  • 2000/9/EC Cableway installations designed to carry persons;
  • 2009/48/EC Safety of toys;
  • 2009/142/EC Appliances burning gaseous fuels;
  • Regulation (EU) No 305/2011 - Construction Materials - Construction products;
  • 2013/29/EU Pyrotechnic articles;
  • 2013/53/EU Recreational craft and personal watercraft;
  • 2014/28/EU - Explosives for civil uses;
  • 2014/29/EU Simple pressure vessels;
  • 2014/31/EU Non-automatic weighing instruments;
  • 2014/32/EU Measuring Instruments;
  • 2014/33 EU Lifts and safety components for lifts;
  • 2014/53/EU Radio equipment;
  • 2014/68/EU Pressure equipment;
  • Regulation (EU) 2016/425 Personal protective equipment;
  • Regulation (EU) 2016/426 - Appliances burning gaseous fuels;
  • Regulation (EU) 2016/424 - Cableway installations.
 

WHY BELPROEKTKONSALTING?

  • efficiency in solving problems (from 1 day);
  • solution of CE-certification tasks for complex technological and production areas;
  • cooperation with numerous European certification bodies with the widest range of accreditations;
  • minimum prices;
  • free consultation.
 

MAIN STAGES OF WORK

Our company offers methodological assistance in passing the CE certification procedure and obtaining the right to apply CE marking in European certification bodies. The general works scheme and documents collection looks like this:
1.Help in the documents set formation for submission to the certification body:
  • general description of products (technical specification, prospectus or any other document);
  • visual drawing;
  • electrical circuitry (if available);
  • detailed drawings of assemblies and parts;
  • risk assessment documentation (risk calculation or safety justification);
  • list of standards used and other technical specifications;
  • technical reports and results of other tests and /or laboratory measurement results (test reports, technical conclusions, etc.);
  • user's manual;
  • copies of documents confirming compliance of other products included in the machine (components);
  • measures that are taken or will be taken to ensure that products comply with the terms of the directive during mass production (quality management system);
  • certificates, declarations and other documents of compliance that are available for the equipment;
  • sample of marking (photo or layout).
2. Application submission to the certification body.