CE Marking: Your Definitive Guide

What is CE Mark / CE Marking?

The CE mark 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 form of the CE mark

The CE mark is a marking that consist of the initials ‘CE’ in the following form:

There are no specific color requirements for the letters and background of the CE mark. In other words, it is not required to print the letters ‘CE’ in black against a white background. However, the color schemes for the foreground and background should be sufficiently complementary, so that the CE logo is clearly visible. The minimum dimension of the CE mark must be 5 mm in height. If the size is enlarged, the letters CE must be in proportion to the standard version as shown. Please find here example of the CE logo in different file formats: http://ec.europa.eu/enterprise/faq/ce-mark.htm The CE mark sometimes is accompanied by a four-digit number. This is a reference number of the Notified Body that has been involved in the conformity assessment process.

Products that need CE marking

Products that require to be CE marked are:

• active implantable medical devices
• appliances burning gaseous fuels (gas appliances)
• cableway installations designed to carry persons
• energy related products
• electronics and active components
• equipment and protective systems intended for use in potentially explosive atmospheres (ATEX equipment)
• explosives for civil uses
• fertilizers
• hot-water boilers
• household refrigerators and freezers
• in vitro diagnostic medical devices
• lifts
• low voltage equipment (electrical material)
• machinery
• measuring instruments
• medical devices
• outdoor equipment producing noise
• non-automatic weighing instruments
• personal protective equipment
• pressure equipment
• pyrotechnics
• radio and telecommunications terminal equipment
• recreational craft
• toys
• simple pressure vessels

The CE marking is not required for the following type of products, for example:

• chemicals
• cosmetics
• foodstuffs
• pharmaceuticals

The list of countries in which CE marking is required

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:

1. Austria (since 1995)
2. Belgium
3. Bulgaria (since 2007)
4. Croatia (since 2013)
5. Czech Republic (since 2004)
6. Cyprus (since 2004)
7. Denmark
8. Estonia (since 2004)
9. Finland (since 1995)
10. France
11. Germany
12. Greece
13. Hungary (since 2004)
14. Iceland
15. Ireland
16. Italy
17. Latvia (since 2004)
18. Lithuania (since 2004)
19. Liechtenstein
20. Luxembourg
21. Malta (since 2004)
22. Norway
23. The Netherlands
24. Poland (since 2004)
25. Portugal
26. Romania (since 2007)
27. Slovakia (since 2004)
28. Slovenia (since 2004)
29. Spain
30. Sweden (since 1995)

The United Kingdom (Great Britain) leaves the European Union at 31 December 2020, and from that moment they will require products to bear the UKCA marking.

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.

CE marking obligations

The following economic operators have obligations regarding CE marking:

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

Manufacturers and importers of products manufactured outside the European Union have the following obligations:

• carry out the conformity assessment, which means that the product must be ensured to comply with the requirements of the applicable European Union CE marking regulations;
• maintain and keep available a Technical File with technical documentation that proves the product conformity with the relevant EU regulations, directives and standards;
• drawing up and signing the EU Declaration of Conformity (DoC);
• affix the CE marking (and possible other conformity markings) to the product;
• ensure the product stays in conformity, even after design modifications or when regulations, directives or standards are amended;
• ensure that the production is well organised and procedures are in place to ensure consistency in the quality of the end product;
• refrain from making the product available if their is doubt about the product safety or (CE) conformity;
• cooperate with the market surveillance authorities from the EU Member States, and follow their instructions.

Authorised representatives may be mandated to perform some of the aforementioned tasks, but they can never take over the responsibility for product conformity.

Distributors and fulfilment service providers have the obligation to verify that the product bears the CE marking, and that the EU Declaration of Conformity and user instructions are available. They also are required to refrain from making the product available in case of doubt about the product safety and conformity.

Importers and distributors that place products in the EU market under their own (brand)name, are considered to have the same obligations as the manufacturer.

Overview of the European Union CE marking directives and regulations

Here is an overview of the main CE directives and regulations. The links will take you to a page with information about the specific directive.

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 – 2014/68/EU
8. RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU
9. Waste Electrical and Electronic Equipment Directive – 2012/19/EU
10. ATEX Directive – 2014/34/EU
11. Toy Directive – 2009/48/EC
12. Radio Equipment Directive – 12014/53/EU
13. Recreational Craft Directive – 94/25/EC
14. Active Implantable Medical Devices Directive – 90/385/EEC
15. Explosive for Civil Use Directive – 93/15/EEC
16. Noise Emission in the Environment Directive – 2000/14/EC
17. Gas Appliances Directive – 2009/142/EC
18. Lifts Directive – 1995/16/EC
19. Pyrotechnic Directive – 2007/23/EC
20. Measuring Instruments Directive – 2004/22/EC

Enforcement of CE marking and sanctions

When a products bears the CE mark it has free access to the market. The EU Member States’ authorities are not allowed to have conditions for market access. 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 marking legislation is performed by national market surveillance authorities of the EU Member States. Enforcement is done in accordance with their national laws and procedures. These national market surveillance authorities work together closely. They share information about non-compliant and unsafe products. They also coordinate their market surveillance campaigns. If a non-compliant CE marked product is discovered in one of the EU countries, all the other market surveillance authorities will be informed about it within 24 hours.