CE Marking Fact Sheet 12.17

CE Marking
The Mark of Compliance With

European Regulatory Requirements
CE marking is proof that a manufacturer can “CE Marking” is part of a Conformity Assessment
demonstrate that its products meet EU System called New Legislative Framework (NLF)
safety, health, or environmental consisting of two regulations (764/2008/EC &
requirements. It is an indicator of a 765/2008/EC) and Decision (768/2008/EC).
product’s overall compliance with EU
The mark shall be affixed by the manufacturer or its
legislation and allows the free movement of authorized representative and a Declaration of
products within the European market. Conformity must be issued. This is a declaration by a
manufacturer that a product meets all the applicable
Intertek helps many companies across a wide legal provisions set by the European Union under the
range of industries meet the regulatory CE marking requirements.
requirements and EU Directives that lead to CE
marking. Our testing expertise, commitment to In the same way the ETL mark can be considered a
excellent service, and global network of “Passport” for your product’s entry into the US and
laboratories and Notified Bodies make us the Canada, the CE marking is your product’s passport
into the European Union.
choice of leading worldwide brands for their CE
marking needs.
Quick Facts About the European Union

• In 2015, the total population living in the EU is 508 million people.*
• More than $1 Trillion worth of goods have been exported from the U.S. into the EU since 2011.*
• CE Marking provides product access to 32 European countries.
* www.statista.com
Who is Responsible for Obtaining a CE Marking?
Ultimately, the organization selling the product to European customers is responsible
for CE Marking. This is normally the manufacturer, but in some cases could be an
independent importer or distributor.
A manufacturer can place the CE Marking on its product only after it has completed
the necessary conformity assessment, created the technical file, and signed a
Declaration of Conformity. All of the manufacturer’s documentation must be made
available upon request by the country AHJs. Importers must gain proof from the
manufacturer that it has met the conformity assessment requirements and can show
proper documentation. Distributors must have similar proof of conformity, as well as
access to the documentation, before they can start selling the product.
If an importer or distributer chooses to sell the product under their own name (e.g.
private label brands), they then will assume responsibility for the product’s CE
Marking and must obtain all of the required information from the manufacturer.
Which Types of Products Require CE Marking

There is no comprehensive list of the products that require a CE marking. It is the
manufacturer's responsibility to determine if the product requires a CE marking. Some
products require conformance to more than one directive. For example, the Safety of
Machinery directive, the Electromagnetic Compatibility (EMC) directive, and the Low
Voltage Equipment directive may all apply to one product.
To find a list of “directives that cover different products or product sectors”, visit
http://europa.eu/youreurope/business/product/ce-mark/index_en.htm.
Does the CE Marking Require A 3rd Party?

Many CE marking directives allow manufacturers to self-certify, or “self-declare”, their
products. Some examples for which manufacturers can self-declare include:
• Machinery Directive
• Electromagnetic Compatibility (EMC) Directive
• Low Voltage Directive
• Class I products of the Medical Device Directive
• Most products covered by the Radio and Telecommunications Terminal
Equipment (R&TTE) Directive
• Radio Equipment Directive
Intertek
545 E. Algonquin Rd. Suite F Directives that do not allow manufacturers to self-declare:
Arlington Heights, IL • Simple Pressure Vessels Directive
60005 • Appliances Burning Gaseous Fuels Directive
T: 1-800-WORLDLAB • Most products covered by the Pressure Equipment Directive
• Most products covered by the Equipment and Protective Systems in
Potentially Explosive Atmospheres Directive
www.intertek.com
For more information, call 1-800-WORLDLAB, email [email protected], or visit

CE Marking 12.14.15
www.intertek.com.

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CE Marking

The Mark of Compliance With

Quick Facts About the European Union

Which Types of Products Require CE Marking

Does the CE Marking Require A 3rd Party?

For more information, call 1-800-WORLDLAB, email [email protected], or visit

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