CE marking is a special mark certifying that the product has passed the evaluation procedure and meets the basic requirements of the directives and harmonized standards of the European Union. CE marking is unique and the only mandatory mark in the countries of the European Union, indicates that the product is not harmful or dangerous for the health of its consumers, and also to the environment. Products that do not have the CE mark are not allowed on the EU internal market, and many non-European countries require their availability.
One of the ways to confirm the conformity of products is a declaration of conformity in which the supplier, in accordance with EN 45014, declares under its sole responsibility that a particular product is in compliance with a specific standard or other normative document to which this declaration refers. At the same time, the supplier must ensure compliance with the required parameters within acceptable limits and control all types of its activities at all stages of production. If the supplier is really able to stably execute and monitor compliance with the requirements of the standard or another document to which it refers in the declaration of conformity, then perhaps this method of establishing compliance will be the most economically viable for such a supplier. Nevertheless, even if all the conditions of EN 45014 are fulfilled, the supplier can share the product liability risk with the certification body by requesting certification of this product by an independent third party.
Classification and basic requirements for the product:
In the evaluation process, products are classified into modules that determine its complexity and safety from the point of view of use. If the product has a minimum risk, it can be certified for its own independent declaration of conformity of products and subsequent application of CE marking on this product. Products that are at high risk must be certified by an independent authorized body.
Certification of products in the countries of the European Union, with the right to apply CE mark on products, is regulated by Decision No. 768/2008 / EC of the European Parliament, adopted on July 9, 2008, under which the following products are considered:
- children’s toys (Directive 2009/48 / EC);
- building products and materials (Regulation 305/2011 / EU);
- personal protective equipment (Directive 89/686 / EEC);
- non-automatic weighing instruments (Directive 2009/23 / EC);
- new boilers (boilers) operating on liquid or gaseous fuels (Directive 92/42 / EEC);
- medical equipment (Directive 2007/47 / EC);
- instruments and protective systems for use in explosive atmospheres ATEX (Directive 94/9 / EEC);
- systems and installations (equipment) operating under pressure Directive 97/23 / EC;
- radio communications and telecommunications terminal equipment (Directive 1999/5 / EC);
- measuring instruments (Directive 2004/22 / EC);
- electromagnetic compatibility (Directive 2004/108 / EC);
- machinery and equipment (Directive 2006/42 / EC);
- low-voltage systems, electrical safety (Directive 2006/95 / EC);
- simple pressure receptacles (Directive 2009/105 / EC);
- combustion appliances for gaseous fuels (gas-fired installations) (Directive 2009/142 / EC);
- explosives for civil purposes (Directive 93/15 / EEC);
- rope installations intended for the transport of people (Directive 2000/9 / EC);
- lifts and lifting mechanisms (Directive 95/16 / EC);
- active implantable medical devices (Directive 90/385 / EEC);
- medical products for laboratory in-vitro diagnostics (Directive 98/79 / EC);
- pleasure crafts (Directive 94/25 / EC).
The CE certification procedure according to the European Directives is divided into modules (certification schemes):
- internal control of production, Declaration of Conformity CE Declaration of Conformity CE Module A;
- internal production control and controlled product testing Module A1;
- internal production control and controlled product testing at random intervals Module A2;
- “CE” examination of a standard sample (CE Certificate CE) Module B;
- compliance with a standard model based on internal production control Module C Declaration of Conformity to type;
- compliance with a standard sample based on internal production control and controlled product tests Module C1;
- compliance with a standard model based on internal production controls and controlled product inspections at random intervals Module C2;
- conformity to the standard sample on the basis of quality assurance of the production process Module D;
- quality assurance of the production process Module D1;
- conformity to a standard sample on the basis of product quality assurance Module E;
- quality assurance of final product control and testing Module E1;
- compliance with the standard model on the basis of product verification Module F;
- conformity based on product verification (CE Certificate of Conformity) Module F1;
- conformity based on product unit verification Module G;
- compliance on the basis of full quality assurance Module H;
- compliance on the basis of full quality assurance and design control Module H1.
Why to certify a product with us?
The company “Certificate Teh Plus” in cooperation with its European partners (accredited certification bodies and testing laboratories) will select the optimal and economically most feasible way of assessing the conformity of products to specified requirements. The cost of this service is formed individually, taking into account the complex of costs for each client: prototypes, transportation costs, travel expenses of the inspector and, not least, the time factor.
In order to start work on product certification within the European Union, you need to contact us via one of the contact phones or send us the following information via email to expert@reglament. by:
1. Name of the product;
2. Customs code of the goods;
3. Technical description or description of the composition of the product;
4. Sphere (area) of application of the products;
5. List of countries in which export is planned;
6. Available documents confirming the safety of the product to European standards, national norms or norms and technical regulations of the Customs Union (if any).
For your convenience, we speak English and Spanish. Best way to contact us in this case is: +375‑29‑3992285 or firstname.lastname@example.org.