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WHICH CE REQUIREMENTS SHOULD MY PRODUCT COMPLY WITH? DOES CE MARKING APPLY TO MY PRODUCT?
What is CE Marking?
CE Marking is NOT a quality-Mark. It is a mandatory conformity marking and refers to Product Safety rather than to the quality of a product.
CE Marking on a product:
- Indicates that the product complies with the essential health and safety requirements of all applicable EU directives.
- A declaration by the manufacturer, or its representative, or the importer that those requirements have been met in full.
- A declaration that all conformity procedures have been completed. The product is allowed in the European market.
- Stands for the French phrase “Conformité Européene” which literally means "European Conformity”.
- Initially "EC Mark" and replaced by "CE Marking" in the Directive 93/68/EEC
 in 1993.
- In cases where the directive requires surveillance by an accredited body, the product carries the individual CE Marking of the Notified body with a four-digit number registered in Brussels. More about SGS Solutions for CE Marking
Many products recalled in Europe carried the CE markings, which are widely misunderstood by consumers. Many consumers assume the CE mark means that toys have been made in Europe and/or have been tested by or on behalf of European authorities: both of these assumptions are wrong.
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Does your product require CE Marking?
- Applies to products placed in the market or put into service in the European Economic Area (EEA).
- About 25 Directives requiring CE marking. It is obligatory for certain product groups such as: Toys, Personal Protective Equipment, Electrical and Electronic Equipment, Medical Devices, Recreational Craft, etc. Sale without a CE Marking within the EU is not allowed.
- The CE Marking is NOT required for the following products: Chemicals, Pharmaceuticals, Cosmetics and Foodstuffs.
- If no EC Directive requiring CE Marking, then CE Marking should not be applied. Application would be considered ‘illegal’. If there is no specific legislation, the General Product Safety Directive (2001/95/EC) applies.
- If multiple Directives apply and require CE Marking, use of CE Marking implies conformity with all applicable Directives.
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Requirements of CE Marking
- A Technical documentation must cover the design, manufacture and operation of the product and includes the test reports for the product.
- All conformity procedures specified with the relevant EC Directive shall be complied with.
- The manufacturer shall draw up a declaration of conformity.
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Who applies to CE Marking?
- The manufacturer, whether established inside or outside the Community (manufacturer may appoint an authorized representative to act on his behalf).
- The person responsible for placing the product on the market may, exceptionally, be deemed to have assumed the responsibilities of the manufacturer.
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Advantages of CE Marking
- Ensures product compliance with the essential requirements of the relevant European health, safety and environmental protection legislation.
- Ensures free circulation of the product within the EFTA & European Union (EU) single market.
- Permits the withdrawal of the non-conforming products by enforcement authorities.
- Reduce liability claims, timescale and costs.
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Affixing the CE Marking
- Must be at least 5 mm in its vertical height.
- Shall be affixed visibly, legibly and indelibly for lifetime of product.
- Shall be affixed on one of the following: the equipment itself, or its packaging, or its instructions for use, or its guarantee certificate.
- May be accompanied by the identification number of a Notified Body involved in assessment.
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SGS Solutions for CE Marking
SGS experts help you determine which CE Directives apply to your products (if any) and which European harmonised standards. SGS is a Notified Body and is able to support you to fulfil the requirements of the CE marking.
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