CE CERTIFICATION (EC OR EU DECLARATION OF CONFORMITY)

THE CE MARKING DOES NOT APPLY IF THE PRODUCT IN QUESTION:

• does not belong to any category within the New Approach directives.
• It will be placed on markets outside the European Economic Area.
• belongs to one of the 3 product categories: Trans-European high-speed rail system; Trans-European conventional rail system; packaging and packaging waste.

What is the presumption of conformity in the CE marking?

The recognition that a product meets the national standards’s requirements including harmonised standards are also compliant with the basic requirements. When the manufacturer doesn’t apply the harmonised standard fully or only partially, they are obliged to document the conformity of the product with the essential directives and the activities they have undertaken to meet these requirements.

Stages of the CE certification process

1. Selection of appropriate directives – i.e. regulations specifying the essential requirements that a product must meet in order to obtain the CE marking. This is done by checking which directives have been assigned to a given product (each product is covered by specific rules of conduct);
   

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2. Selection of the conformity assessment procedure module – in the directives there are modules of product conformity procedures, marked with letters A to H. Before launching a product on the market, each product undergoes such a procedure, in accordance with the assigned directive. The manufacturer themselves decides on the choice of procedure;
   

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3. The use of harmonised standards – these are optional, detailed requirements for a given product. They complement New Approach directives’ essential requirements. The manufacturer selects them from among the standards assigned to a particular product. Harmonised standards can be very helpful, because in many cases they facilitate the procedure transition – their application may result in a presumption of conformity with the essential standards. In some cases they also allow avoiding the necessity of testing the product by a notified entity. An updated list of standards is available at www.pkn.pl;
   

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4. Product risk analysis – the manufacturer is obliged to check what risks are generated by their product (according to the applicable standards). This enables the introduction of appropriate security measures, minimising any potential risk. Although not every directive requires the manufacturer to document such an analysis, it is worth to enclosing the results;
   

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5. Optionally – adjusting the product or production process to the applicable regulations – if tests and analyses show that the product does not meet the directives’ standards, it must be adjusted to them – this may apply to the product as a whole, its part or production process;
   

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6. Preparation of technical documentation in the CE certification process – after analysing and introducing possible changes, it is necessary to prepare the product technical documentation, which contains the confirmation of compliance with the New Approach directives. The manufacturer must complete the technical documentation. This can be done with the assistance of an appropriate consulting company (e.g. as part of our legal services);
   

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7. Preparation of the declaration of product compliance with the directive requirements – once again it is a document prepared by the manufacturer or their appointed representative. Such a letter allows us to presume that a number of requirements have been met, to guarantee high quality and product safety. By signing the compliance declaration, the manufacturer certifies the product’s compliance with the basic requirements, and then stores it together with the technical documentation for 10 years;
   

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8. Marking the product with the CE mark – passing the above mentioned stages entitles the product to be branded with the CE mark. The manufacturer is responsible for the marking – the CE must be affixed to each piece of the product in a permanent, non-removable and legible form, with a minimum size of 5 mm.