Guide to understanding the CE marking

What is the CE Marking?

The CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The letters “CE” stand for “Conformité Européenne,” which translates to “European Conformity.”

The CE mark indicates that a product has been assessed by the manufacturer and meets EU safety, health, and environmental protection requirements. By affixing the CE mark, manufacturers declare that their products comply with all relevant EU regulations and directives. It is mandatory for certain products within the EEA to have it, ensuring they can be sold and moved freely within the market.

When is CE marking mandatory?

CE marking is mandatory for products that fall under one or more of the 25 CE directives or regulations. If a product does not fall under any of these, affixing the CE mark is prohibited. To determine if a directive or regulation applies to a product, consult the specific scope and definitions of the directive, as well as any exceptions.

Products requiring CE marking

Machinery (Directive 2006/42/EC)
Noise emission equipment for outdoor use (Directive 2000/14/EC)
Cableway installations (Regulation (EU) 2016/424)
Energy-related products (Directive 2009/125/EC)
Appliances burning gaseous fuels (Regulation (EU) 2016/426)
Toy safety (Directive 2009/48/EC)
Electrical equipment (Directive 2011/65/EU)
Pyrotechnic articles (Directive 2013/29/EU)
Hot water boilers (Directive 92/42/EEC)
Explosives for civil uses (Directive 2014/28/EU)
Simple pressure vessels (Directive 2014/29/EU)
Electromagnetic compatibility (Directive 2014/30/EU)
Weighing instruments (Directive 2014/31/EU)
Measuring instruments (Directive 2014/32/EU)
Lifts (Directive 2014/33/EU)
Equipment for potentially explosive atmospheres (Directive 2014/34/EU)
Electrical equipment for certain voltage limits (Directive 2014/35/EU)
Radio equipment (Directive 2014/53/EU)
Recreational craft (Directive 2013/53/EU)
Pressure equipment (Directive 2014/68/EU)
In vitro diagnostic medical devices (Regulation (EU) 2017/746)
Construction products (Regulation (EU) No 305/2011)
Medical devices (Regulation (EU) 2017/745)
Personal protective equipment (Regulation (EU) 2016/425)
Unmanned aircraft systems (Regulation (EU) 2019/945)

The CE marking is not required for pharmaceuticals, chemicals, cosmetics, food and products that do not fall under the above directives.

If you are unsure about your specific product, please don’t hesitate to contact us so that we can get back to you with an explanation for your specific needs!

Does Amazon require the CE marking?

Amazon and other e-commerce platforms increasingly enforce product safety regulations. For certain product categories, Amazon requires pre-approval and the submission of the Declaration of Conformity. It is crucial to complete the CE marking process before selling products on these platforms to ensure compliance.

Benefits of the CE Marking

Free movement of goods: Products can move freely between EEA member states without any trade barriers.
High level of protection: Ensures a high standard of health, safety, and environmental protection for consumers.
Market access: Acts as a passport for the European marketplace, enabling easier access and distribution.

Countries accepting the CE marking

The CE marking is accepted in all 27 EU countries, Iceland, Liechtenstein, and Norway, as part of the EEA. It allows for the free movement of goods within these countries. Additionally, CE marked products can be sold in Switzerland, United Kingdom and Turkey, despite these countries not being EU or EEA members, due to their adoption of CE marking directives.

The economic operators

First, let us define the different economic operators:
The manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and places it on the market under his own name or trademark.
The importer is the economic operator established in the Union who places a product from a third country on the Union market.
The authorised representative acts as a liaison between the manufacturer and MSAs, regardless if the manufacturer is placed in the EU or not.
The distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market. A distributor can purchase a product from the manufacturer or the importer and sell it within the EU. This may mean they make a product available in a new member state.
Fulfilment service providers are any natural or legal person offering, in the course of a commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved.

Responsibilities

Manufacturers are responsible for ensuring that products comply with CE marking requirements, completing the conformity assessment, compiling the technical documentation, and affixing the CE mark.
Importers must ensure that non-EU manufactured products comply with EU requirements before placing them on the market. They must verify the manufacturer’s compliance, including the completeness and authenticity of the technical documentation. They must further verify that the product is labelled correctly and also ensure to label the product with their name and contact details or ensure that the name and contact details of an authorised representative is present on the product and/or packaging. They are also obliged to ensure that the user information is translated according to the national laws to which they import the product.
Distributors must ensure that products they distribute comply with applicable regulations. If they modify a product or market it under their own name, they take on the responsibilities of the manufacturer. They must also ensure that the product is correctly labelled with the manufacturer’s and possibly also the importer’s or the AR’s names and contact details. They are also obliged to ensure that the user information is translated according to the national laws to which they distribute the product.

The CE marking process

The CE marking process usually consists of the following six steps, but this is not the only way to achieve it. The final result is what matters but the following is a well accepted approach as described by the EU commission:

Identify applicable legislation: Determine which directives and regulations apply to the product.
Verify product requirements: Ensure the product meets specific requirements of the identified directives.
Determine conformity assessment necessity: Identify if an independent conformity assessment by a notified body (NB) is necessary.
Conduct conformity assessment: Perform the assessment, either through self-certification or involving a NB.
Compile technical documentation:Prepare and maintain a technical file with all required documentation.
Affix CE marking: Place the CE mark on the product and draw up the EU Declaration of Conformity.

visualisation of 6 step process to get the ce marking

CE marking self-certification

Self-certification allows manufacturers to conduct the CE marking process without a notified body for most products. However, some directives require third-party testing and certification by a NB, especially for higher-risk products like medical devices and pressure equipment.

CE certification costs

The costs can vary widely depending on the product and certification procedure, ranging from 0 EUR to over 100000 EUR. Factors influencing costs include the need for third-party testing, the complexity of the product, and the scope of technical documentation required.

CE marking logo requirements

The CE mark must adhere to the following guidelines:

The initials “CE” must be in the standard, predefined form. Click here to download it in various file formats.
The marking must have a height of at least 5 millimetres.
The mark should be affixed to the product, data plate, packaging, or accompanying documents.
The marking must be visible, legible, and permanent.