CE Marking and European Medical Device Directive 93/42/CEE
Edited by Larry C., Newlook Marketing, 4-Aug-2005.
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 literaly means "European Conformity".
The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.
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.
It proves to the buyer or user that this product fulfills all essential safety and environmental requirements as they are defined in the so-called European Directives.
CE Marking Grid
What CE Marking means:
- CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
- CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries).
- CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.
To us, our products bearing the CE Marking also mean a passport to gaining access to the EFTA & European Union market.
European Medical Device Directive 93/42/CEE
European Medical Device Directive 93/42/CEE contains the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform.
Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc).
See the Council Directive 93/42/EEC (.pdf) of 14 June 1993 concerning medical devices. Multi-lingual translation by EUROPA, the portal site of the European Union:
Appendix
- CEN stands for European Committee for Standardization.
- CENELEC stands for European Committee for Electrotechnical Standardization.
- The European Union (EU) includes the following 25 Member States: Austria, Belgium, Denmark, Estland, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, The Netherlands, Czech Republic, UK and Cyprus. These Member States differ in their constitutional and legal systems.
- The European Free Trade Association (EFTA) countries comprise Iceland, Liechtenstein, Norway and Switzerland, with the exception of Switzerland which does not enforce CE Marking.
Reference
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