Guide to the CE marking legislation
The CE marking is a crucial aspect for any importer, manufacturer, or distributor intending to sell products within the European market. This guide aims to provide a comprehensive guide, covering essential aspects such as its meaning, mandatory requirements, processes, and the responsibilities of various stakeholders involved.
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
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
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:
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:
Conclusion
Understanding and complying with CE marking requirements is essential for selling products within the
European market. By following the outlined steps, manufacturers, importers, and distributors can ensure their
products meet the necessary standards, enabling smooth market access and consumer protection.
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and how we can help your products achieve compliance with ease or contact us now: