CE Certification: The CE stands for Conformite Europeenne, which means European Conformity. The CE mark aims to ensure that only safe, faultless, and high-quality goods are offered in the European market. CE marking is required for many products sold in the EEA (EU plus Iceland, Lichtenstein, and Norway). CE marking verifies that your product has been tested and fulfills EU safety, health, and environmental protection standards. It applies to products manufactured both inside and outside the EEA and then sold within the EEA.
To receive the CE certification on your product, you'll need to put up a technical dossier demonstrating that it meets all of the EU's regulations. As the manufacturer of the goods, you are solely responsible for declaring compliance with all standards. Once your product has received the CE mark, you may be required to give all CE-related documents to your distributors and/or importers.

What is CE Marking?

CE Certification or Marking is only required for products that meet EU criteria and are marked with the CE symbol. The initials CE on commercial products indicate that the maker or importer certifies that the product complies with European wellbeing, protection, and ecological protection regulations. It is not a certification and it does not indicate the quality of the product. Its main purpose is just to sell the products in European Economic Area (EEA) freely.

Documents Required for CE Certification

  • Product Details/description
  • Product test Report
  • Manufacturer Declaration
  • Proof of product conformity
  • Copy of Risk Assessment

How to obtain CE Marking?

  1. Identify EU Requirement - The first step to get CE Mark is to decide which product and model are certified with a CE mark. And also identify the European requirements, does product meet EU requirements or not.

  2. The product meets Specific Requirements - After identifying the EU Requirements, the next step is to check whether products meet specific requirements or not, which are mandatory for the CE Mark, and also identify the directives applicable and harmonic standards applicable for the product. Some of the directives are a medical device, machinery device, toy, low voltage, LVD, etc.

  3. Product Test - Once the product fulfills all the requirements, the product needs to be tested (in-house/outside) according to the directive and standard requirement.

  4. Compile the technical dossier - Prepare the Technical construction file of the product, which is to be CE marked, and forward it to the certification agency involved in CE Registration/certification.

At last, affix the CE marking and draft a declaration of conformity.

Note: Self-certification allows some products to be CE marked. This isn't the case with every product, either. Some products require the involvement of a CE mark notification agency/competent entity to be marked. When self-declaration is not an option, CE marking certification/registration organizations must be consulted from the beginning of the product design process.


Options for products with minimal risk include self certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product.

Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body". This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union.

frequently asked questions (FAQ)

    CE is a manufacturer's declaration that a product meets the necessary health, safety, and environmental requirements established in the relevant European product legislation and has undergone the relevant conformity assessment method is known as marking on a product

      CE mark is mandatory to sell products in European Economic Area (EEA).

        The CE mark and EC Declaration of Conformity are valid as long as your product complies with the directive's applicable health, safety, and environmental standards (s). If the product (or component) undergoes changes in design or features, it may be necessary to test it to ensure that it remains compliant with the relevant directive. Furthermore, changes to the applicable legislation and/or harmonized standards may necessitate retesting the product to establish compliance.

          Netherland, Bulgaria, Romania, Luxembourg, France, Germany, Italy, Ireland, Denmark, Greece, Spain, Portugal, Austria, Finland, Sweden, Cyprus, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovenia, Slovakia, Czech Republic.

            The government of the relevant member state can take action if a product is marked with the CE label illegally. Products may be pulled from the market, and penalties may be applied. If the CE mark has been fixed unlawfully or if the product does not satisfy the standards stipulated by the EU harmonized standards, manufacturers, importers, and/or authorized representatives will be held accountable.

              If a non-EU manufacturer makes the device, the person who commercializes it in the EU assumes all of the responsibilities that would normally fall on the manufacturer or their authorized representative and must ensure that the device meets the essential requirements and submit all relevant documentation for control purposes, if necessary.
              This system does not apply if created by an EU company, and liability cannot be transferred to a third party (distributor, user, etc.). When an authorized EU agent is involved, this is also true.


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