About CE Marking and Notified Body

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What is CE marking?

The CE marking is a conformity process consisting of the symbol Image result for ce symbol. The symbol indicates that the product is affixed to conforms to all relevant essential requirements and other applicable provisions that have been imposed upon it by means of European directives, and that the product has been subject to the appropriate conformity assessment procedures. The essential requirements refer, among other things, to safety, public health and consumer protection.

The CE marking is mandatory for all products that fall into one of the Community directives relating to the CE marking in the European Union member countries. Applicable directives are depending on the type of product. For each directive is available the list of harmonized standards to which the product must be submitted, so it is not possible to affix the CE mark without first making all the tests specified by the regulations.

The CE marking must be affixed by the manufacturer always, even if he is a resident outside the European Union, in order to be allowed to sell his product in the European market.

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What is a Directive?

A European Directive can be regarded as an European law and is legally binding for every Member State of the European Union. Through transposition into the national legislation of the Member States, persons and companies are subject to the requirements of the European Directives.

What is a Notified Body?

For some directives, the European Union considered that the manufacturer alone could need an external evaluation of their technical files or, in some cases, a real endorsement required by an independent body.

Notified Bodies are the only recognised third party bodies that can carry out a conformity assessments laid down in the relevant harmonised European standards or European Technical Assessment.

A list of all officially designated Notified Bodies is available in the database Nando.

CELAB Ltd. is Notified Body nr. 2559, recognized by the European Union, for :

NOTICE: Only UE/Type Certificate certificates issued as a notified body have legal force and can be used in areas of law. The certificates do not report the number of the volunteers and are not issued with those purposes.

CELAB Ltd. is accredited EN ISO/IEC 17020:2012 by NAB Malta (National Accreditation Body).

The ‘Blue Guide’ on the implementation of EU product rules 2022

The European Union published the  “Blue Guide”, the main reference for understanding the rules relating to the activities of CE marking of products that are placed on the European market.

Download the BLUEGUIDE

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