CE MARK

PROCESS ANALYSIS
MIT 608
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WHAT IS CE MARKING?

The letters "CE" stand for "Conformit Europenne" ("European Conformity").

CE marking (also known as CE mark) is a mandatory conformance mark on many products placed on the market in the European Economic Area (EEA). With the CE marking on a product the manufacturer ensures that the product is in conformity with the essential requirements of the applicable European Community(EC) directives.
It shall indicate conformity to all obligations imposed on the manufacturer, as regards his products , by virtue of the European Community directives providing for the affixing of the CE marking.
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HISTORY

Existing in its present form since 1993 By affixing the CE marking on a product, a manufacturer is declaring, on ones sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area. The European Economic Area (EEA) was established on 1 January 1994 following an agreement between the member states of the European Free Trade Association (EFTA, led Sweden) and the European Community, later the European Union (EU). This also applies to products made in third countries which are sold in the EEA CE marking does not indicate that a product was made in the EEA Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked.
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COUNTRIES REQUIRING THE CE MARKING

The CE marking is mandatory for certain product groups in the European Economic Area (EEA), 30 full members of EEA Austria, Belgium, Bulgaria, Cyprus, Czech Republic , Denmark Finland, Estonia, France, Germany, Greece, Hungary, Iceland Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia Spain, Sweden, United Kingdom

EUROPEAN ECONOMIC AREAS (EEA)

WHICH PRODUCTS REQUIRED THE CE MARKING?

MACHINERY

WHICH PRODUCTS REQUIRED THE CE MARKING?

ELECTRICAL AND ELECTRONIC EQUIPMENT

WHICH PRODUCTS REQUIRED THE CE MARKING?

MEDICAL DEVICES

WHICH PRODUCTS REQUIRED THE CE MARKING?

TOYS

WHICH PRODUCTS REQUIRED THE CE MARKING?

PERSONAL PROTECTIVE EQUIPMENT (PPE)

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RULES UNDERLYING CE MARKING

The manufacturer of a product himself affixes the CE marking to it, but has to take certain obligatory steps before the product can bear CE marking. He has to carry out a conformity assessment, set up a technical file and sign an EC declaration of conformity. Products that are subject to certain EC directives providing for CE marking, have to be affixed with the CE marking before they can be placed on the market Manufacturers have to check on their sole responsibility, which EU directives they need to apply for their products The product may only be placed on the market if it complies with the provisions of all applicable directives and if the conformity assessment procedure has been carried out accordingly

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RULES UNDERLYING CE MARKING

The manufacturer draws up an EC declaration of conformity and affixes the CE marking on the product If stipulated in the directive(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure If the CE marking is affixed on a product, it can only bear additional markings under the condition that they are of different significance, do not overlap with the CE marking and are neither confusing nor impairing the legibility and visibility of the CE marking

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RULES UNDERLYING CE MARKING

Example Diagram for the conformity assessment procedures established by the Directive 73/23/EEC on electrical equipment.

Technical File The manufacturer draw up the technical documentation covering the design, manufacture and operation of the product.

EC declaration of conformity The manufacturer guarantees and declares that his products are in conformity to the technical documentation and to the directive requirements.

Manufacturer

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RULES UNDERLYING CE MARKING

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CHARACTERISTICS OF THE CE MARKING

The CE marking has to be affixed by the manufacturer or its authorized representative in the European Community according to its legal format visibly, legibly and indelibly to the product The size of the CE marking must be at least 5 mm, if enlarged its proportions have to be kept If the appearance and workmanship of a product do not allow for the CE marking to be affixed on the product itself, the marking has to be affixed to its packaging or accompanying documents If a directive requires the involvement of a Notified Body in the conformity assessment procedure, its identification number has to be put behind the CE marking. This is done under the responsibility of the Notified Body.

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MISUSE

The European Commission is aware that CE marking, like any other mark, is misused. CE marking may sometimes be affixed to products which do not fulfill the requirements and conditions for its affixing or it is affixed to products for which the affixing is not foreseen. There are also cases where, the product is in compliance with the applicable requirements the CE marking itself does not respect the formal requirements, namely the form of the CE marking or the dimensions and proportions prescribed in the legislation.
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CHINA EXPORT

The CE symbol has been alleged or believed to stand for China Export or China Electronics because some Chinese manufacturers apply a very similar marking to their products. As Chinese exporters have used the CE logo incorrectly, the matter was raised at the EU parliament in 2008, and the Commission responded that they will look into trade-marking the logo, and are in discussion with Chinese authorities to ensure compliance with European standards.
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IMPORTANT TO NOTE: WHAT CE MARKING IS NOT: A QUALITY MARK

AN INDICATION OF ORIGIN AN APPROVAL OF AN AUTHORITY
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IMPORTANT TO NOTE: CE MARKING IS:

IT IS A CONFORMITY MARKING THAT GIVES PRODUCTS ACCES TO THE EUROPEAN UNION MARKET. THE MANUFACTURER MAY ONLY AFFIX THE CE MARKING WHEN HE/SHE HAS ENSURED THE COMPLIANCE WITH HEALTH, SAFETY AND ENVIRONMENTAL REQUIREMENTS.
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END

THANK YOU FOR LISTENING

Presented by: Alexander Obida

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