The Importance of CE Marking for you with Questions and Answers
|Another significant “first in Turkey quality” comes from Doğtaş Mattress:
Doğtaş Mattress is the first Turkish mattress company with CE Medical Device Certificate!
In other words Doğtaş Mattress is officially different from all competitors…
• Doğtaş Mattresses are manufactured after an intensive and fastidious product design effort of eight months managed by the Doğtaş R & D Department and Doğtaş Mattress applied to ITC (Institute for Testing and Certification Inc. Zlin-Czech Republic) as the Notified Body.
• After the scientific research conducted by the ITC Doğtaş Mattress’s benefits for body health is documented and proven.
• Accordingly Doğtaş Mattresses are certified with 93/42/EEC Medical Device Directive Class 1 CE Certificate on September 2007.
• With this quality certificate Doğtaş Mattress is the first brand in Turkey which is included in the medical bed category.
• Doğtaş Mattresses are being imported to Europe with 07 04 37 V/ITC Certificate as a medical device and they also meet the national customers.
What is CE Marking?
CE Marking name is derived from “Conformité Européenne”s abbreviation which means “European Conformity".
CE marking is a Union sign which shows that the products carry it meets all the appropriate provisions of and confirms with 21 New Approach Directives which was included in the New Approach Policy- technical harmonization legislation accepted by the European Community in the year of 1985.
CE Marking declares that the products baring this sign would not harm human, animal or vegetation health or the wellbeing of environment in general as long as they are used according to their production purpose; in other words it declares that the products carrying CE sign are safe.
What if the product does not have a CE Marking?
Those products which are included in the product category of CE Marking yet found inappropriate for this marking can not be exported to EU countries. Furthermore, as the legislation harmonization process is completed and above mentioned directives came to affect such products –those do not confirm with and do not bare the CE Marking- will not be able to sold even in the domestic market.
What are the basic principles of CE Marking?
By placing the CE Marking on his products the responsibility holder declares that the product confirms with all relevant Union legislations and that it has been tested and approved.
• CE Marking is a mandatory sign and unless mentioned otherwise in a special directive the mark must be placed on the product before it is released to the market.
• If the product is included in more than one directive than carrying the CE Mark means that the product confirms to all applicable directives.
• In the case of product not being included in any directives than CE Marking is not done.
• CE Marking is to be attached to the product either by the manufacturer or his Authorized Representative within the Union.
• If the size of the marking is to be enlarged or reduced it is necessary to keep the original proportions.
• CE Marking has to be placed on the product or the product information card in an easy to see and easy to read manner without a possibility of fading away. If doing so is not possible due to the characteristics of the product than the sign may be affixed on the product packaging or attached to the product documents if any.
• According to the relevant directives’ legislation if the product is currently in the process of Production Control by a Notified Body then Notified Body’s ID number should also be mentioned with the sign. The manufacturer or his Authorized Representative located within the Union would attach the sign and ID number under the responsibility of the Notified Body.
How to Affix the CE Marking?
Manufacturers are responsible for releasing their products in the market with the sign attached. However if the manufacturer and his representative is not within the Union then the importer is to fulfill this responsibility. In other words the importer has to guarantee that the products imported by him comply with the EU norms.
What is Notified Body? What is its function?
Notified Bodies act as a third party and handle conformity evaluation procedures as indicated in the related New Approach Directives. Notified Bodies’ main duty is to evaluate conformity according to the applicable Directives and they are to provide conformity evaluation services within their field of approval to any domestic or international economic actor. Manufacturers on the other hand are free to choose any domestic or international Notified Body authorized to handle Conformity Evaluation Procedure according to the relevant Directive.
EU Countries declare national conformity evaluation companies which they find technically qualified as Notified Bodies to the Commission. The list of Notified Bodies determined by the member countries are announced to the other members in the EU Official Paper.
Criteria of technical adequacy and capability of handling conformity evaluation procedure guidelines, independence, neutrality and honesty are taken into consideration while evaluating the company which is to be declared to the Commission.
These are basic sufficiency criteria for the Notified Bodies as indicated in the Directives:
• Personnel and equipment competence.
• Being independent and neutral when people and companies who and which are directly or indirectly related to the product (manufacturer, manufacturer’s authorized representative, supplier, installer, operator etc.) are concerned.
• Adequate technical qualification of the personnel related to the products and conformity evaluation procedure.
• Providing occupational secrecy and having Occupational Responsibility Insurance unless supplied by the State.