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 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
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
MD - Machinery Directive
EMC Directive - Electromagnetic compatibility
LVD - Low Voltage Directive
Noise Directive - Noise Emissions by equipment for
PED - Pressure Equipment Directive
SPVD - Simple Pressure Vessels Directive
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
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
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
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