About CE marking
‘CE’ stands for Communauté Européenne (European Community).
Introduced in 1995, CE Marking was created to stimulate the free circulation of goods within the European Community.
What does CE marking signify?
CE marking when applied to any product or equipment indicates that the manufacturer or its authorised EU representative has declared that the product or equipment complies with all applicable European Directives.
Who can perform CE marking?
The company that places the product or equipment on the market is responsible for declaring that the item is compliant with all applicable EU Directives and placing the CE marking on the product or equipment. The responsibility for CE marking will fall on the manufacturer if the manufacturer is EU-based and selling products directly or the manufacturer’s agent within the European Union if the manufacturer is based outside of the European Union. Third parties cannot apply the CE marking or make declarations of conformity unless they are responsible for placing the product in the EU.
Who is responsible for affixing the CE marking?
The manufacturer of a product is responsible for ensuring compliance with European Directives and for affixing the CE marking – irrespective of whether the manufacturer is located within or outside the European Union. To do this, manufacturers may appoint an authorised representative established in the European Union to act on their behalf.
The CE marking is generally a declaration by the manufacturer, importer, or the entity first placing the product on the market that the product conforms to the appropriate directives. This is confirmed by the legally binding signature on the Declaration of Conformity.
I am a manufacturer, importer, or entity placing the product on the market. When do I have to affix the CE marking?
For you as a manufacturer, importer, or entity first placing the product on the EU market, CE marking is mandatory if your product is covered by a CE Marking Directive. By fixing the CE marking to your product, you are responsible for ensuring that your product complies with the requirements of all relevant EU Directives and for providing documentary evidence of conformity.
If you fail to deliver the requisite evidence of conformity in your capacity as a manufacturer or importer, the competent market surveillance authority may prohibit you from placing your products on the market.
How is a Declaration of Conformity made?
The declaration of conformity is a written document which is available to the purchaser of any CE marked equipment.
Do I need to publish the Declaration of Conformity?
No, the only requirements are that the purchaser has a copy and that the original is kept in the technical file.
Is there a specified format for Declarations of Conformity?
The format for a declaration of conformity is defined within the directives applicable to the product. In the case of many electrical machines, the declaration should incorporate the requirements of the Machinery Directive, the EMC Directive and the Low Voltage Directive.
The required content for declarations covering the above directives can be found below.
Declaration for Machinery directive
Declaration for EMC directive
Declaration for Low Voltage directive
What am I doing when I sign a Declaration of Conformity?
When a Declaration is made, you are declaring that the product conforms to all applicable directives and these will be listed in the declaration. In many declarations, the signatory is effectively stating that the equipment is safe. If the equipment is found to be non-compliant, the national enforcement authorities within the European Union will have the name of the company and the name of the signatory to pursue legally or otherwise.
What is a technical file?
The technical file contains all the evidence required to support the declaration of conformity. Each directive specifies the content of the technical file. The technical file requirements for each directive are different, so a technical file which supports a declaration of conformity covering a range of applicable directives must include all of the required sections from all applicable directives. Technical files must be retained and made available for inspection when requested by an enforcement authority for a period defined in the directive. In the case of the machinery directive, the period is 10 years after the last product was manufactured.
Where should the technical file be kept?
The technical file must be kept within the EU, but can be stored electronically and compiled as a single document. However, when required by the enforcement authorities, it must be made available within a timescale acceptable to them.
Do I need a Quality system?
There is a requirement in some Directives (e.g. the Machinery Directive) to implement a system which ensures continued compliance of products if they are manufactured in series, but not all directives have of this requirement.
Gaining a competitive edge with the CE marking through a Notified Body certification or opinion.
The CE marking itself is solely a means to facilitate the free passage of goods throughout Europe and to demonstrate compliance with uniform safety standards. Although CE markingis mandatory, you can still use it to carve out a competitive profile for your company and your machinery by asking a recognized EU Notified Body such as TÜV SÜD Product Service or TÜV SÜD BABT to assess your products and by showing the Notified Body's registration number alongside the CE marking on your product. CE marking thus becomes an opportunity for you to standards to your customers that your product has been independently assessed against all applicable standards.
TÜV SÜD Product Service – your experienced partner for all CE marking related issues