The countries of the European Union assume that products bearing the CE mark comply with all the provisions of the relevant directives. Accordingly, the placing on the market of these products bearing the CE marking shall not be prohibited, restricted or prevented unless the provisions relating to the CE marking are applied incorrectly.
Products covered by the New Approach Directives have the CE Marking. In particular, the CE Mark therefore indicates that the products comply with the essential requirements of the applicable directives and that the products are subject to the conformity assessment processes specified in the directives. In this context, countries included in the European Union are obliged to take adequate measures to protect the CE marking.
The New Approach directives apply to products intended for the first time to be offered to consumers within the European Union. In general, these products are ready-to-use or require adjustments that can only be made for their intended use. In short, the directives apply to new products manufactured in European Union countries and to new products imported from third countries and used or second hand products. The product concept varies among the New Approach directives. The directives include, for example, equipment, apparatus, devices, tools, materials, assemblies, components or safety components, accessories or systems. The manufacturer must therefore check whether a product is covered by one or more directives.
Products that are subject to significant changes are considered new products that must comply with the provisions of the applicable directives when presented to their markets in European Union countries. Products that have been repaired without altering their original performance, intended use and shape are not subject to conformity assessment according to the New Approach directives.
The basic requirements set out by the New Approach directives may overlap or complement each other, depending on the hazards covered by those conditions associated with the product in question. Where the same product or hazard falls within the scope of two or more directives, the application of other directives may sometimes be excluded by performing a risk analysis of the product for the intended use defined by the manufacturer.
Manufacturers within or outside the European Union are responsible for affixing the CE marking to products covered by the New Approach Directives. In general, the CE certification process takes place in six steps:
Identify the directives or directives to which the product applies. The first step is to determine which directives the product falls under.
Identify the requirements for the product. Each directive details what is legally required for product compliance.
To determine if third-party assessment is needed. Some directives require that products be tested and approved by a third-party organization to ensure compliance with the applicable basic requirements.
Evaluate product suitability. The directives contain eight conformity assessment modules. These modules are applicable to a specific product category and are identified as follows: Module A Internal production control, Module B European Union type examination, Module C Type compliance, Module D Production quality assurance, Module E Product quality assurance, Module F Product verification, Module G Unit verification and Module H Full quality assurance.
Prepare and store technical files. Producers are required to create a technical dossier containing information and documents indicating that the product complies with the directive requirements and keep it for at least 10 years from the date of manufacture.
Make a declaration of conformity and affix the CE mark. The declaration of conformity is a declaration of conformity with the CE marking directives.
Our company also provides CE certification process services within the scope of certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.
CE certification process services provided within the scope of certification services are only one of the services provided by our organization in this direction. Many other certification services are also available.