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CE-Marking: the "technical passport" for your products in Europe

CE stands for Communauté Européenne (European Community) and

demonstrates the compliance of a product according with the

specific decisive European guidelines.

If your products have to be provided with the CE mark or not, is

regulated in the EU-directives. Following we would like to

clarify the most asked questions regarding the CE-marking.

The CE mark is not a certificate
The CE mark was created in 1985 by the Council of Ministers of

the EU in an effort to achieve technical harmonization and reduce

impediments to trade. Many products, such as toys, electric

appliances or equipment for do-it-yourselfers, can only be sold

by manufacturers and retailers in the EC when they have the CE

mark. This may be awarded when the product complies with

one or several of the existing 20 relevant EU guidelines. The

CE mark signals to the supervising authorities, whose responsibility

it is to randomly check on the fulfillment of legal requirements,

that a product complies with the relevant guidelines (which, by

the way, do not describe any details, since this is reserved for

standards) for the prevention of health, safety or environmental

hazards. Manufacturers and importers themselves affix the CE

mark. They also have to supply the declaration of conformity

and the documentation which is normally required. Consequently,

the CE mark is neither a certificate nor a quality mark from a

certification body accredited in the EU, but "only" a voluntary

declaration on the part of the manufacturer or importer,

as well as the often-cited technical "passport" to the Union

and the European Economic Community.

CE Marking
CE Marking has been a challenge for manufacturers of machinery

and process equipment since the Machinery Directive became

mandatory in 1995. If you plan on selling your equipment in

the European Union, be sure to partner with a third party

that can help you navigate the requirements of the Machinery Directive.

When the European Union was founded, one of the stated goals

was to create a single European market by removing trade barriers

that existed among the EU Member States. This has been achieved

through the introduction of many European Directives into law,

and particularly a group of directives known as the "New Approach"

directives. These directives share, in part, the requirement of CE Marking

the product that is to be traded in the European market place.

The basic meaning of the CE Marking on your product is that the product

has characteristics that could impact the safety or well-being of people,

and that you have designed and appropriately evaluated your

product to ensure such characteristics present no significant risk.

There are many different directives that call for CE Marking. Your

product may fall under the scope of one or several of them. The single

CE Marking indicates that your product conforms to any and all

applicable directives.

The technical requirements of the CE Marking directives are typically

found in an Essential Requirements Annex, or appendix, to the directive.

You may work with TÜV to demonstrate conformance to the essential

requirements by direct analysis and testing, or through the use of

standards that have been specifically identified for use with the directive.

In addition to laying out technical requirements, the CE Marking directives

detail the process by which your equipment's conformance must be

verified and documented. Each of the directives allows for some level

of involvement of a Competent Body or Notified Body in the conformity

assessment procedure, how much involvement is dependent upon equipment

type. These bodies are organizations officially recognized in the European

Union as having the expertise, experience and quality systems to competently

assess the technical requirements.

CE Marking Directives Often Applicable to Machinery and Process Equipment

98/37/EC

 MD - Machinery Directive

2004/108/EC

 EMC Directive - Electromagnetic compatibility

73/23/EEC

 LVD - Low Voltage Directive

2000/14/EC

 Noise Directive - Noise Emissions by equipment for

 use outdoors

97/23/EC

 PED - Pressure Equipment Directive

87/404/EEC

 SPVD - Simple Pressure Vessels Directive

94/9/EC

 ATEX Directive - Equipment andprotective

 systemsinpotentially explosive atmospheres

CE Marking and the Pressure Equipment Directives
There are CE Marking directives related to pressure systems that may also

be applicable to your machinery: the Pressure Equipment Directive and

the Simple Pressure Vessel Directive. TÜV provides Notified Body

services for the Pressure Equipment Directives through its parent

company Group TÜV Süddeutschland Bau und Betrieb GmbH.
The
Pressure Equipment Directive is probably the most applicable

to industrial machines and processing equipment, and yet most

manufacturers are unaware of its impact and requirements. It became

a mandatory requirement for equipment entering the European Union

on May 29th, 2002. If the machinery you produce contains gas or liquid

systems operating above 0.5 bar (approximately 7.25 psi) you should

investigate the application of this directive. It is likely that many of the

components encompassed within your equipment will not require any

rigorous assessment, but there will be a few components that may

require the involvement of a Notified Body.

The Simple Pressure Vessel Directive is less commonly an issue.

Although it is has the same pressure threshold of 0.5 bar, it is

focused only on vessels containing air or nitrogen that have a very

simple method of construction. You should be aware of this directive

whether you manufacture simple pressure vessels or utilize them in

your machinery.

Engineers from EUT Product Service's Machinery Evaluation

group can assist you in understanding the impact of these directives

as part of the evaluation of your equipment to the Machinery

Directive. If Notified Body involvement is required, we can guide you

through the process. For more information visit our Pressure Equipment

Services page.

CE Marking and the ATEX Directive for Explosive Atmospheres
If your machinery or process equipment is intended to operate

in a potentially explosive atmosphere or may create an explosive

atmosphere, the Directive for Equipment Used in Explosive

Atmospheres may apply. This directive is also known as the ATEX Directive.

Contact us directly for more information on this very specialized field of

machinery evaluation.
Conformity Assessment
The requirements of the directives apply to your products when they

are made available within the territory of the European Union.

This includes used products, one-of-a-kind machines and even machinery

 to be used in factories belonging to the manufacturer. To avoid being

turned away at EU borders, you must be sure that your products:

Meet the essential requirements of all applicable directives

Have a proper technical documentation file available

Have your correctly written Declaration of Conformity (D.O.C)

Have the CE marking properly affixed

  

 

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