Steps to Get CE Certification

The member countries of the European Union (EU) take for granted that the products bearing the CE mark comply with all the provisions of the applicable directives. Consequently, the placing of the products bearing the CE Mark in the market shall not be prevented, restricted, or prohibited until and unless the provisions relating to the CE marking are enforced incorrectly.

Products covered under the New Approach Directives have the CE Marking. The CE Mark therefore implies that the products comply with the essential requirements of the relevant directives and that they are subject to the conformity assessment processes specified in those directives. On this basis, the member countries of the European Union are obligated to take adequate measures to protect the CE marking.

The New Approach directives are applicable to the products intended to be offered to consumers for the first time within the EU. In general, these products are either ready-to-use or require adjustments that can only be made for their intended use. In brief, the directives are applicable on new products manufactured in EU member countries and on the new products imported from third countries or second hand products. The concept of product varies among the New Approach directives. For example, the directives include, accessories or systems, materials, equipment, assemblies, apparatus, components or safety components, devices, tools etc. Thus, the manufacturer must check if a product is covered by more than one directives.

Products which are subject to significant changes are treated as new products and they must comply with the provisions of the respective directives before being presented in the markets of European Union countries. Products which have been refurbished without altering their original shape, performance and intended use are not subject to conformity assessments as per the New Approach directives.

The basic requirements outlined by the New Approach directives may complement or overlap each other, subject to the hazards covered by those conditions associated with the product up for discussion. Where the same product or hazard falls within the scope of more than one directives, the application of other directives can sometimes be excluded by performing a risk analysis of the intended use of the product that is defined by the manufacturer.

Manufacturers outside or within the EU are liable for affixing the CE Mark on the products covered by the New Approach Directives. In general, there are 6 steps to CE certification process:

  1. Identifying the directives or directives to which the product applies. The first step is to determine which directives the product falls under.
  2. Identify the requirements of the directive(s) for the product. Each directive details out what is legally required for product compliance.
  3. Determine the need for third-party assessment. Some directives require that products be tested and approved by a third-party organization to ensure compliance with the applicable basic requirements.
  4. Evaluation of product suitability. The directives consist 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.
  5. Preparing and storing technical files. Producers are required to create a technical dossier containing documents and information indicating that the product complies with the directive requirements and keep it for a minimum period of 10 years from the date of manufacture.
  6. Making a declaration of conformity and affixing the CE mark. The declaration of conformity proves that the product complies with the mandatory safety requirements and is established on the basis of technical file.

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