Ce Marking is a health and safety symbol, which is implemented within the framework of “New Approach” constituted by European Union (EU) in 1985, so as to ensure free movement of goods. It was intended that, instead of various conformity symbols used in throughout EU, a unique EU symbol be used which designates conformity with the directives. CE Marking is the symbol of conformity with the EU New Approach Directives, which shows that the product on which it has been affixed is healthy and safe for the purposes of people, domestic animals and environment. It is not possible for a product within the scope of one or one or two New Approach Directives, the number of which is now 25, to be put on the EU market without bearing CE Marking. It is of basic importance that the manufacturers manufacture conformable to the harmonised standards involving directives in proving the conformity with the New Approach Directives. Even if conforming to the standards is not mandatory, in case of manufacturing conformable to the standards, the presumption of conformity with the directives stimulates the manufacturer to conform to the standards.
CE Marking is not a quality mark. It means the product on which it has been affixed meets all the requirements of the related directive and appears so as to ensure free movement of goods among the Member States of the EU.
CE Marking of conformity consists of the capital letters in the form of the figure below.
If CE Marking of conformity is minimised or enlarged it must be fit in with the ratios given above.
WHICH PRODUCTS MUST BEAR CE MARKING?
Products within the scope of the directives involving CE Marking given in the following table,
All new products which have been manufactured in the Member States and in third countries,
Second-hand products imported from third countries,
Products subject to the provisions of the directives as if new products and products which have undergone a change significantly must bear CE Marking.
PROCEDURES OF AFFIXING CE MARKING;
Directive(s) involving the product is/are determined.
(If exist) Harmonised Standards are identified.
Module or combination of modules is/are selected.
Whether Notified Body is required or not is determined.
Subsequent to conformity assessment, declaration of conformity and if required other documents are prepared.
Technical file is prepared and retained.
“CE” Marking is affixed to the product and/or on its package and on the accompanying certificate and the product is put on the market.
CE DIRECTIVE AND THE CE MARKING
The 'CE' abbreviation stands for 'Communauté Européenne,' French for 'European Union.' It also stands for EU-wide standards, which simplify the traffic of European goods.
REGULATORY EXAMPLES
Low Voltage Directive for Electric Operational Products: 2014/35/EU
Active Implantable Medical Devices: 90/385/EEC
Pressure Equipment Directive: 2014/68/EU
Simple Pressure Vessels: 2014/29/EU
Toy Safety: 2009/48/EG
Building materials: VO (EU) 305/2011
Machines: 2006/42/EG
Electromagnetic Compatibility (EMC): 2014/30/EU
Personal Protective Equipment (PPE): 89/686/EEC (from 21.4.2018: VO (EU) 2016/425)
Ecodesign requirements for energy-using products: 2005/32/EG
Medical Products: 93/42/EEC
Lifts: 2014/33/EU