CE, or the European conformity mark, covers many products. This marking characterizes an adequate level of safety for a product. Who is subject to CE certification?
It is the common name for the process of evaluating the conformity of a product with the requirements contained in European regulations and standards related to that product. This mark informs the user that the product is safe and legally placed on the market.
This marking may be affixed by the manufacturer of the product in question, or by a representative authorized by him. This means that neither importers nor distributors can do this. There are no external bodies that assign the CE marking. There are situations in which tests have to be performed by an external laboratory, but it is up to the manufacturer of the product to assign the mark and meet all the requirements.
The marking has been obligatory in Poland since 2004, when the country was incorporated into the European Economic Area. All devices, for which the mark is intended, must be marked with it. This must be done before placing the product on the market or putting it into service. This means that you cannot use the equipment before it is CE marked.
Manufacturers are obliged to CE mark their products:
– electrical and electronic equipment
– radio equipment
– personal protective equipment,
– fireworks and other explosives for civil uses,
– pressure products and simple pressure vessels,
– boats and yachts,
– devices: linear, measuring, gas-fuel burning and non-automatic weighing devices,
– medical devices, including those for active implantation and in vitro diagnostics
– construction products, boilers and equipment operating in potentially explosive atmospheres.
The marking is not applied when the manufactured or imported product does not belong to any of the categories specified in the EU New Approach Directives. CE marking is also not applied to products placed on markets outside the European Economic Area.
The CE mark is also not required for packaging and packaging waste, the trans-European high-speed rail system and the trans-European conventional rail system.
It is also important to remember that the CE marking is neither a quality mark nor an indication of the origin of the product. This means that the manufacturer does not have the possibility to use it freely, on a voluntary basis.
This is a very detailed process, which may cause difficulties for manufacturers. In this situation it is advisable to seek legal advice. Detailed information on this subject can be found here: https://rpms.pl/certyfikacja-ce-deklaracja-zgodnosci-we-lub-ue/.
To obtain the CE mark, first the essential requirements that must be met by the product must be determined. Then you have to choose the appropriate module of the conformity procedure, which is marked in the regulations. The essential requirements are supplemented by detailed harmonized standards. However, they are not mandatory. The manufacturer chooses them from among the standards assigned to a given product. They may be helpful as they make it easier to go through the procedures.
The next step is an analysis of hazards that may be posed by the product. This allows to minimize the risk. Then the appropriate technical documentation has to be drawn up. This confirms that the product meets the requirements of the regulations. Then a declaration of conformity of the product is created. By signing such a declaration, the manufacturer certifies the compliance of the product with the essential requirements
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