Products, which are supposed to be imported to the territory of the EU, must have a CE mark on it.
The CE marking must be on the following products:
- All new products, regardless of whether they are produced in the countries of the EU or other countries
- Products of secondary products, imported to the EU from abroad
- Modifications of products, which were marked with CE earlier
Placing CE mark is possible only after passing through the procedure of conformity to related norms and standards of the EU. After this manufacturer will obtain certificate or declaration. It depends on type of products.
It is necessary to match products to a Directive, which will determine the form of conformity.
- Directive 2009/105/EC Simple pressure vessels (SPVD)
- Directive 89/686/EEC Personal protection equipment (PPE)
- Directive 92/42/EEC Hot-water boilers, operated with liquid and gas fuel
- Directive 93/42/EEC Medical devices (MDD)
- Directive 94/9/EC Equipment and protection systems intended for use in potentially explosive atmospheres (ATEX)
- Directive 95/16/EC Lifts and lifting mechanisms
- Directive 97/23/EC Pressure equipment (PED)
- Directive 1999/5/EC Radio and telecommunications terminal equipment (R&TTE)
- Directive 2000/14/EC on noise level in environment
- Directive 98/79/EC on in-vitro diagnostic medical devices (IVDD)
- Directive 2000/9/EC relating to cableways installations designed for transporting people
- Directive 2006/95/EC Low voltage equipment (LVD)
- Regulation (EU) № 305/2011 on construction materials and constructions
- Directive 2004/108/EC Electromagnetic compatibility (EMC)
- Directive 2006/42/EC Machines and mechanisms(MD)
- 2010/35/EC Transportable pressure equipment
- Directive 88/378/EEC Safety of toys
- Regulation EU 305/2011 «Establishment of harmonized conditions for spread on the market of construction products and cancelling Directive 89/106 / EEC
- Directive 89/686/EEC «Approach of the legislation systems of the EU Member States concerning to personal protection equipment
- Directive 90/384/EEC Non-automatic weighing devices
Directives of the EU determine basic requirements for products, which is supposed to be imported to the EU market. They also determine requirements for quality and safety of products. However, they leave rights to a manufacturer to choose instruments of achieving appropriate level of safety and quality.
Many types of products are covered by several Directives:
- Following documents are needed for expert’s conclusion on obtaining an ATEX certificate:
- Description of proper use of product, its functionality, operational manual
- Specification with all requirements for products
- Functional block diagram
- Scheme of elements and parts
- List of all components related to security, the precise indication of a type and article number. It has to be done in a table form, with indication of manufacturer of each component
- The data tables and, if necessary, the declaration of compliance for this product
- Image (photo) of the product and the main components (parts) in various projections
- If it is supposed to export products to countries outside the EU, these countries must be specified
Stages of obtaining CE Certificate
- Definition of the Directive, according to which certification procedure will be carried out
- Expert examination of submitted documents
- Expert inspection of production premises
- Working out a technical file
- Carrying out of tests
- Issuing of CE Certificate
The validity of CE certificate depends on the type of products.
All documentation must be provided in one of the languages of the EU.
Declaration process is similar to certification process, but expert inspection of production premises is not usually carried out.
Manufacturer (applicant) takes full responsibility for reliability and accuracy of data.