What is the CE marking?

The CE marking is a method by which the manufacturer or importer declares that their product complies with the relevant legislative requirements and confirms that the necessary assessments have been carried out, with the entire responsibility resting on the manufacturer.

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Who are the stakeholders involved in CE marking?

The manufacturer (whether located within or outside the EEA).

The manufacturer of products made outside the European Union has the following obligations :

  • Conduct conformity assessment, which means ensuring that the product complies with the requirements of the European Union regulations applicable to CE marking.
  • Maintain and provide access to a technical file containing the technical documentation that proves the product’s compliance with the applicable EU regulations, directives, and standards.
  • Write and sign the EU declaration of conformity.
  • Affix the CE marking (and possibly other conformity markings) to the product.
  • Ensure that the product remains compliant, even after design modifications or when regulations, directives, or standards are changed.
  • Ensure that production is well organized and that procedures are in place to guarantee the consistency of the final product’s quality.
  • Be prepared to isolate the product in case of doubts about its safety or compliance (CE).
  • Cooperate with the market surveillance authorities of the EU member states and follow their instructions.

Authorized representatives may be mandated to perform some of the aforementioned tasks, but they can never assume responsibility for the product’s compliance.

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Importers and Distributors (whether located within or outside the EEA).

The importer and/or distributor is obligated to ensure that the product carries the CE marking and that the EU declaration of conformity and user instructions are available (to be requested mandatorily from the manufacturer). They are also required to isolate and remove the product in case of doubts about its safety and compliance

Importers and distributors who place products on the EU market under their own name (brand) are considered to have the same obligations as the manufacturer.

Authorized Representatives (whether located within or outside the EEA).

the aforementioned tasks, but they can never assume responsibility for the product’s compliance.

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CE – A key indicator of compliance.

The CE marking is a key indicator of a product’s compliance with the European Union (EU) directives and regulations on health, safety, and environmental protection.

If your product falls within the scope of a directive requiring CE marking, you must ensure that the product complies with the applicable requirements and affix the CE mark before placing it on the market in the European Economic Area (EEA). This also applies if your product is manufactured outside the EEA.

CE marking allows the free movement of products within the European market. We describe this CE marking as a commercial passport within the European Union, as per European legislation. EU member states allow free circulation of any product bearing the CE mark on the European market, provided that the requirements set by the applicable directives are met and compiled in a file ready to be presented to interested parties upon request. The CE mark does not indicate that a product was manufactured in the European Union. The CE mark is not a proof of product quality.

What type of product do you wish to CE certify?

A toy

Toys are subject to directives such as 2009/48/EC.

    The physical and mechanical properties of the toy, its flammability, chemical, electrical, and hygienic properties, etc., must be analyzed. Can the toy contain carcinogenic, mutagenic, or toxic substances? There is a long list of elements to check. Simply send us a request, and our experts will take care of explaining everything to you.

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A radio equipment

Radio equipment is subject to directives such as 2014/53/EU.

    The electromagnetic properties must be analyzed by an accredited third party. Additionally, the electrical and/or electronic characteristics of the equipment must also be verified. Simply send us a request, and our experts will take care of explaining everything to you. 

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Personal protective equipment

Les protections individuelles sont soumise à des directives tel que – 89/686/CEE

   Beyond simple impact resistance, there is a long list of elements to check for personal protective equipment. Simply send us a request, and our experts will take care of explaining everything to you.

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Medical devices

Medical devices are subject to directives such as 93/42/EEC.

   Beyond verifying standards aimed at preventing risks associated with the design, manufacture, and packaging of medical devices, there is a long list of elements to check. Simply send us a request, and our experts will take care of explaining everything to you.

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Machinerie & Robotique

Robotics and machinery are subject to Directive 2006/42/EC.

There are a multitude of machines, each with its own specific features. Therefore, there is a long list of elements to check to ensure your machine or robot can obtain CE marking. Simply send us a request, and our experts will take care of explaining everything to you.  

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Elevators, EMC, construction products, gas appliances, noisy, electrical, electronic, under pressure, measuring devices…

Our CE marking methodology is proven effective.

We determine the applicable CE rules for our clients, certify compliance, prepare the required documents, and keep our clients informed of regulatory changes.

The 6 steps of the CE marking process:

  • Identify the applicable directives and harmonized standards for the product.
  • Verify the product-specific requirements.
  • Determine if an independent conformity assessment by a notified body (authorized third-party) is required.
  • Test the product and verify its compliance with European legislation (conformity assessment procedure).
  • Establish and keep available the technical documentation required by the directives.
  • Affixing the CE marking on your product and issuing the CE Declaration of Conformity
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We are committed to supporting and guiding you through the process of harmonization with European regulations.
Karla Martinez
Advisor CE, Consultant

Any questions?

We assist the manufacturer in affixing the CE marking when all marking requirements are met. Testing or certification bodies may be involved in the process as service providers.

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