What is CE Mark?

A CE marking is a self-certification required for applicable products entering/being placed on the market in the EU.  The CE certification mark signifies that the product meets applicable directive requirements as clarified below.  All EU countries require CE certification, and some countries that are not official EU members also require CE certification. For more information on our CE Services, see CE Mark Certification Service.

The CE marking signifies the manufacturer’s declaration that a product meets the requirements of the applicable EC directives (formerly referred to as “New Approach Directives”).  The first step in the process is to identify whether or not the product is required to bear the CE mark.  Not all products are required to bear the CE marking, only the products that fall within the scope of at least one of the EC directives require it.  There are more than 20 EC directives.  The following are some of the more prominent directives:

• Low Voltage Directive (2014/35/EU)
• Machinery Directive (2006/42/EC)
• EMC Directive (2014/30/EU)
• Medical Device Directive (93/42/EEC)
• Radio Equipment Directive (2014/53/EU)
• RoHS (Restriction of Hazardous Substances) Directive (2011/65/EU)

Identifying which directive(s) are applicable to a product requires someone (preferably with a technical background) to review the scope of each directive, and establish which apply to the product in question. If the product does not fall within the scope of any of the directives, the product is not required to bear the CE mark, and in fact is precluded from bearing the CE marking.  Please refer to the following link for an up to date, complete list of the EC Directives

Each Directive has slightly different methods of demonstrating conformity depending on the classification of the product and its intended use. Every Directive has a number of ‘essential requirements’ that the product has to meet before being placed on the market.

The best way to demonstrate that these essential requirements have been met is by meeting the requirements of an applicable ‘harmonized standard,’ which offer a presumption of conformity to the essential requirements, although the use of standards usually remains voluntary. Harmonized standards can be identified by searching the ‘Official Journal’ on the European Commission’s website, or by visiting the New Approach website established by the European Commission and EFTA with the European Standardization Organizations.

A sample of a CE compliance decision path for a computer is illustrated below.  The orange arrows show a branch of the path drilled down to the safety report level.  In the illustration it can also be seen how different products have different paths to compliance.

The format of the mark is regulated.  The letters “CE” are drawn from two circles, laid out according to Figure 1. The vertical size may not be less than 5 mm.  Normally, the mark will be placed in a visible spot on the outside of the equipment, but in cases where that is impractical, it may be included on the packaging and/or documentation.

Figure 1 – CE Mark Diagram

It is important to note, that in addition to the mark itself, some Directives require that additional information accompany the mark or the Declaration of Conformity.  Depending on the quality assurance module chosen, the identification number of the notified body responsible for EC surveillance of the quality system may have to be added.

New Recast Directives now require the manufacturer to mark their address on the product itself unless space is not available.

The new Low Voltage Directive (2014/35/EU) now requires a risk assessment be conducted on equipment.  This directive does not require that the mark be accompanied by any additional information. However, the declaration of conformity must include the following items:

1. Product model/product (product, type, batch or serial number):
2. Name and address of the manufacturer or his authorized representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the declaration (identification of electrical equipment allowing traceability; it may include a color image of sufficient clarity where necessary for the identification of the electrical equipment):
5. The object of the declaration described above is in conformity with the relevant Union harmonization legislation:
6. References to the relevant harmonized standards used or references to the other technical specifications in relation to which conformity is declared:
7. Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

G&M can help you through the process of compliance with the following directives:

Low Voltage Directive – LVD

Machinery Directive – MD

Electromagnetic Compatibility Directive – EMC

Medical Devices Directive – MDD

Radio Equipment Directive – RED

See more at:  CE Certification page