cemarking.net

The CE marking is a key indicator (but not proof) of a product’s compliance with European Union (EU) health, safety and environmental protection directives and regulations.

If your product comes under the scope of a directive requiring CE marking you must ensure the product complies with the applicable requirements and affix the CE mark before placing it in the market in the European Economic Area (EEA) (see “Countries In Which The CE Marking Is Required” below for a description of the countries that are included in the EEA). This is equally valid if your product is manufactured outside the EEA. Second hand products from outside the EEA that are placed in the EEA market for the first time, also require CE marking.

Often the CE marking is described as a trade passport because it enables the free movement of products within the European market. According to EU legislation, the EU Member States are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product. CE marking does not indicate that a product was made in the European Union. The CE mark also is not a quality mark.

Please note:

• you cannot affix the CE mark to products which are not covered by the relevant European directives;
• by affixing the CE marking, you take full responsibility for your product’s compliance with the requirements of the relevant directives;
• other markings may be affixed to the product as long as that such markings do not create confusion with the CE marking in form or meaning.

The CE marking is not required for items, for example:

• chemicals
• cosmetics
• foodstuffs
• pharmaceuticals

The CE marking is affixed on the aforementioned products that will be placed on the EEA and Turkish market, whether they are manufactured in the EEA, in Turkey or in another country.

The CE marking is currently required in the following countries:

Switzerland is not a member of the European Union, but for some products it accepts the CE marking as a presumption of conformity with Swiss national technical regulations.

Persons that bear a responsibility for CE and the CE compliance of products are:

• manufacturer (irrespective if located in our outside the EEA)
• importer
• distributor
• authorised representative

If you are a manufacturer it is your responsibility to:

• carry out the conformity assessment
• draw up the Technical File
• issue the EC Declaration of Conformity (DoC)
• affix the CE mark to the product

 If you are the importer a product from a third country you have to check that the manufacturer outside the EU has undertaken the necessary steps. You must check that the documentation is available. However, if you import the product but place it in the EU market under your own (brand)name, you have the same obligations as the manufacturer.

If you are a distributor you must check the presence of both the CE mark and the user manual, product label and other necessary supporting documentation.

Despite what many people believe, a manufacture does not “get” the CE mark from a third party certification body or a European or national authority. The manufacturer affixes the CE marking in his own right and is allowed to do so when all requirements are fulfilled. A test or certification body may be involved in the process merely as a service provider. However, the body will not take over responsibility for CE compliance. Responsibility for CE compliance will always remain with the manufacturer (or private labeler).

The CE marking rules typically require the following steps to be fulfilled before the CE mark may be affixed:

As indicated, products with that bear the CE mark have a free access to the market in the sense that the authorities are not allowed to require all kinds of requirements to be fulfilled. However, that does not mean that the authorities have no right to investigate the product’s compliance. Not only can they investigate, but they can also take measures against infringements. These measures may include withdrawal, recall of products, penalties and criminal sanctions (such as fines and imprisonment) wherever necessary.

Please note that there is not a single, European Union enforcement agency or service. Enforcement of CE legislation is performed by national market surveillance authorities, in accordance with the national laws and procedures of the Member States of the EU. These national market surveillance authorities work together closely, sharing information about non-compliant and unsafe products, as well as coordinating their market surveillance campaigns. If a non-compliant CE marked product is discovered in one market, all the other market surveillance authorities will be informed about it by the next morning.

1. Machinery Directive – 2006/42/EC
2. Low Voltage Directive – 2014/35/EU
3. EMC Directive – 2014/30/EU
4. Medical Devices Directive – 93/42/EEC
5. Personal Protective Equipment Directive – 89/686/EEC
6. Construction Products Regulation – Regulation (EU) No 305/2011
7. Pressure Equipment Directive – 97/23/EC
8. REACH – Regulation (EC) No 1907/2006
9. RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU
10. Waste Electrical and Electronic Equipment Directive – 2012/19/EU
11. ATEX Directive – 2014/34/EU
12. Toy Directive – 2009/48/EC
13. R&TTE Directive – 1999/5/EC
14. Recreational Craft Directive – 94/25/EC
15. Active Implantable Medical Devices Directive – 90/385/EEC
16. Explosive for Civil Use Directive – 93/15/EEC
17. Noise Emission in the Environment Directive – 2000/14/EC
18. Gas Appliances Directive – 2009/142/EC
19. Lifts Directive – 1995/16/EC
20. Pyrotechnic Directive – 2007/23/EC
21. Measuring Instruments Directive – 2004/22/EC

As well as information and explanations about CE marking related requirements such as: