CE Marking
consulting & EU representation
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What is CE Marking?
CE Marking is the symbol 
as shown on the top of this
page. The letters "CE' are the abbreviation of French phrase
"Conformité Européene" which literaturely means
"European Conformity". The phrase was initially "CE Mark" and later it was replaced by "CE
Marking". "CE-Marking" is also in use, but not so often.
- CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations, in practice by many of the so-called product Directives.*
- CE Marking indicates to governmental officials that the product may be legally offered for sale in their country.
- *product directives contains the "essential requirements" or
"performance levels" and sometimes so-called "Harmonized Standards" to
which the products must conform. Harmonized Standards are the technical
specifications which are established by several European standards agencies
(CEN, CENELEC, ETSI and EOTA).
Along with more directives' becoming effective, more and more products are
required to carry the CE Marking for gaining access to the European
market. However, many non-EU exporters are still unaware of or unsure
about this fact and its impact on their business.
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Why is CE Marking called the "Passport to Europe" for non-EU products?
The European Union's 'New Approach directives' are mandatory on all member countries to enact through national legislation.
This legislation requires manufacturers to display CE Marking on their product for packaging and accompanying literature. Where a new approach directive is in force, it is (with few exceptions) an offence to place a product on the market without CE Marking. The manufacturer is legally responsible for ensuring that the product confirms to the requirements of the directive and for applying CE Marking.
CE Marking is one important measure that the EU has adopted to establish the
single market and foster economic development for the member states. The objective of the directives is to simplify the movement of goods into and within the EU.
This may eventually lead to the free movement of goods throughout Europe as more and more european countries are expected to join the EU. The European Commission thus refers to the CE Marking as a "Passport" which allows products to be freely circulated within the EU single market.
Often customers will look for CE Marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality which other products may lack. CE Marking is thus considered by many customers as a "Symbol of Quality."
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How does CE Marking
effect the export to Europe?
If the new product directives apply to your products and you want to
continue to export to the European market (or introduce new products),
then CE Marking will be crucial to your success. The CE Marking can be, at the same
time, of both benefits and disadvantages.
Benefits:
- With this "passport" your products can easily gain access to the entire EU plus EFTA market.
- There will be only one set of laws and regulations for the
entire marketplace which guide the designing, manufacturing and labeling
of products. The multiple and conflicting national restrictions on
regulated products will be eliminated. Thus the CE Marking on your product will make your trade with EU countries cheaper and easier.
- Your product will be made safer for consumers and thus the damage
claims and liability premiums will be reduced.
Disadvantages:
- New product directives may exceed the current national laws and
regulations. It may cost a manufacturer extra to modify the currently
existed design and/or production line in order to continue exporting
to or gain access to this huge European market.
- Extra costs in obtaining the product certification for CEM and any,
if applicable, required testing certification.
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page
How many countries
are currently requiring products to bear CEM?
Total 18 countries for the time being. These are the 15 European Union (EU) member countries: Austria, Belgium, Denmark,
Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, the Netherlands,
Portugal, Spain, Sweden and United Kingdom (Great Britain) plus the European
Free Trade Association- EFTA's 3 member states: Iceland, Liechtenstein and Norway. This number could soon increase significantly when EU admits new member states.
The 12 European countries on application to become EU Member states have started to adopt the CE-Marking requirements to ensure that their products can freely move throughout the EU member States in the future.
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How many directives exist there today?
Here is a list of directives
directive
code |
TITLE |
DATE OF APPLICATION BY MEMBER STATES |
END OF TRANSITION PERIOD |
| 73/23/EEC |
electrical equipment
(low voltage) |
1 Aug 1974 |
- |
| 87/404/EEC |
simple pressure vessels |
1 July 1990 |
1 July 1992 |
| 88/378/EEC |
toys |
1 Jan 1990 |
- |
| 89/106/EEC |
construction products |
27 June 1991 |
special case |
| 89/336/EEC |
electromagnetic compatibility |
1 Jan 1992 |
31 Dec 1995 |
89/392/EEC
repealed by 98/37/EC |
machinery |
1 Jan 1993 |
31 Dec 1994 |
| 89/686/EEC |
personal protective equipment (ppe) |
1 July 1992 |
30 June 1995 |
| 90/384/EEC |
non-automatic weighing instruments |
1 Jan 1993 |
1 Jan 2003 |
| 90/385/EEC |
active implantable medical devices |
1 Jan 1993 |
31 Dec 1994 |
| 90/396/EEC |
appliances burning gaseous fuels |
1 Jan 1992 |
31 Dec 1995 |
91/263/EEC
repealed by 98/13/EC |
telecom terminal equipment (tte) |
6 Nov 1992 |
special case |
| 92/42/EEC |
efficiency of liquid or gaseous fueled hot water boilers |
1 Jan 1994 |
31 Dec 1997 |
| 93/15/EEC |
explosives for civil uses |
1 Jan 1995 |
31 Dec 2002 |
| 93/42/EEC |
medical devices |
1 Jan 1995 |
13 Jun 1998 |
93/97/EEC
repealed by 98/13/EC |
satellite earth station equipment |
1 May 1995 |
special case |
| 94/9/EC |
equipment used in potentially explosive atmospheres |
1 March 1996 |
30 Jun 2003 |
| 94/25/EC |
recreational craft |
16 Jun 1996 |
15 Jun 1998 |
| 97/23/EC |
pressure equipment |
29 Nov 1999 |
29 May 2002 |
94/C70/07
96/C22/06 |
(proposal) cableway installations for passengers |
not stated |
not stated |
| 95/16/EC |
lifts |
1 July 1997 |
30 June 1999 |
| 96/57/EC |
energy efficiency: household refrigerators & freezers |
18 Oct 1999 |
18 Oct 2002 |
| 95/C172/02 |
(proposal) in vitro diagnostic medical devices |
1 Jul 1998
(proposed) |
4 years
(proposed) |
| 98/13/EC |
telecom terminal equipment & satellite earth station equipment |
1 Apr 1998 |
none |
97/C248/04
98/C141/08 |
connected telecommunications equipment. amended proposal |
not stated |
not stated |
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Does my product need
CEM?
CEM is most probably required if you export to the above mentioned 18 EU plus EFTA member states these types of products as listed below.
- appliances (other than gas)
- construction products
- electrical equipment
- equipment and protective systems for explosive atmospheres
- gas appliances
- in vitro diagnostic medical devices
- lift machinery
- machinery
- marine equipment
- measuring instruments
- medical devices
- non-automatic weighing equipment
- personal protective equipment
- simple pressure vessels
- recreational craft
- satellite station equipment
- telecommunications
- toys
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Which directives are most frequently complied with?
There are 4 directives which are most frequently complied with. When more than one directives apply to a product, the product must comply with all applicable directives
The electromagnetic compatibility directive
Became effective on 1/Jan/1996. This directive applies to most electronic equipment which has electromagnetic emission.
The low voltage directive
Has been in application since 1/Aug/1974 and became effective for CEM in Jan/1997. This directive applies to all electrically operated products.
The machinery directive
Became effective on 1/Jan/1995 and covers any machine with moving parts (except manually operated machines).
The medical devices directive
Became effective on 14/Jun/1998. This directive requires an authorized representative located within EU states and Certificate of Registration of product in EU. (click here to see a sample of Certificate of Registration)
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How to obtain CEM for my product?
There are a series of steps outlined below. Depending upon your product and
the nature of the risks it presents:
- Determine if any directives apply to your product. If more than one
applies you will have to comply with all of them.
- Determine the extent to which your product complies with the essential
requirements for design and manufacturing in the applicable directive(s).
- Choose the conformity assessment procedure from the options called
out by the directive for your product.
The directives often use a series of questions about the nature of your
product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the
acceptable options available to a manufacturer to certify their product
and affix the CEM.
Minimal Risk
Options for products with minimal risk include self certification where
the manufacturer prepares a Declaration of Conformity and affixes
the CEM to their own product.
Greater Risks
Many directives require products/systems with greater risks to be
independently certified; this must be done by a "Notified Body". This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a
government agency. Manufacturers may choose a notified body in any member
state of the European Union. Lists of notified bodies are published by the
European Commission in the Official Journal of the European Communities.
A Notified Body is usually able to offer some of the services required:
- product testing
- type examination certificate issue
- Technical File and design dossier evaluation
- surveillance of product and quality system
- identification of standards
If your products need to be certified by a Notified Body, then you will need to do as follows:
- Select the applicable product standards and test methods for your
product and select a Notified Body.
- Establish an authorized representative in the European Union for
your product.
Some directives require that a manufacturer designate in the European Union
an authorized representative to produce Technical Documentation (or sometimes called Technical File) in a timely fashion when called upon to do so. The CEM itself is not meant to provide details about the product to Surveillance Authorities.
- Technical Documentation (Technical File): The directives require for many products that a Technical Documentation (Technical File) be prepared by the manufacturer. The Technical Documentation (Technical File) holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.
- Prepare a Declaration of Conformity.
The Declaration of Conformity must contain information adequate for
tracing the product back to the manufacturer or the authorized representative
in the European Union. It may include a list the
directives and standards that your product conforms to, product
identification, the manufacturer's name, address and signature.
- Affix the CEM to your product.
There are specific rules to adhere to in
CEM. These rules address the size and location of the Marking; affixing the
CEM to products, packaging and material or documents shipped with the product;
and specific limitations on when and who is permitted to affix the CEM.
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Who's going to enforce the requirement for CEM?
Each member state of the EU is bound by the General product Safety directive to adopt laws, regulations and administrative provisions to ensure that products placed on the market are safe. Each country has its own way of handling enforcement.
Many have added staffs specifically to conduct spot checks against implemented directives and respond to complaints. Countries have also set in place a combination of Return-to-Origin procedures, financial penalties, etc.
EU legislation makes EU importers liable for the products they import, including the machinery they provide to their employees for work. Many non-EU exporters are finding that no matter how interested a prospective EU importer may be in the product, the importer will NOT risk importing non-conforming products (i.e. the products without CEM) which, in case of accident, may generate legal action against them.
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How can Wellkang
Consultant Firm Sweden help regarding CEM?
- We can offer you expert consulting services in English, in Chinese, in French, in Portuguese, and /or in Spanish.
- We sell all the directives, some of which are translated to other languages, e.g. in English, in Chinese, in French, in Portuguese, and /or in Spanish.
- We can arrange the testing of your products by a Notified Body in Sweden or other EU countries.
- We can help you to prepare the Declaration of Conformity and Technical Documentation (Technical File) in different languages, e.g. in English, in Chinese, in French, in Portuguese, in Spanish and more.
- We can be your EU authorized representative and keep the necessary documents, e.g. Declaration of Conformity and Technical Documentation (Technical File), available for being immediately verified by vigilance and enforcement authorities.
- We can act as your EU authorized representative and register your products in Sweden or other EU countries for the CEM for certain kind of products, e.g. medical devices.
- Please contact us for more information.
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