Difference between revisions of "Notified body"

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(Created page with "A '''notified body''' is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. The European Commission publishes a list of such notified bodies. <small>(Source: [https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/notified-bodies_en...")
 
 
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A '''notified body''' is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. The European Commission publishes a list of such notified bodies.
A '''notified body''' is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to [[conformity assessment]] procedures set out in the applicable legislation, when a third party is required. The European Commission publishes a list of such notified bodies.


<small>(Source: [https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/notified-bodies_en European Commission, Notified bodies])</small>
<small>(Source: [https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/notified-bodies_en European Commission, Notified bodies])</small>
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== In easy words ==
== In easy words ==


In some cases indicated by law manufacturer can carry out the activities relating to the CE marking independently, including the preparation of the EU declaration of conformity, even if we advise companies to rely on at least an expert consultant (especially for the preparation of the risk analysis and the dossier technician in general, requiring specific skills).
In some cases indicated by law manufacturer can carry out the activities relating to the CE marking independently, including the preparation of the [[EU declaration of conformity]], even if we advise companies to rely on at least an expert consultant (especially for the preparation of the [[safety risk analysis]] and other documents of the [[technical file]], requiring specific skills).


In other cases, however, the manufacturer cannot self-certify that the product is safe (even if, in addition to preparing the technical file, he has verified that the product is safe through specific laboratory tests), but must request that the certification be carried out by a specific third party body, i.e. a notified body.
In other cases, however, the manufacturer cannot self-certify that the product is safe (even if, in addition to preparing the technical file, he has verified that the product is safe through specific [[laboratory tests]]), but must request that the certification be carried out by a specific third party body, i.e. a "notified body".


==Do you need help in preparing your product and related documentation for a notified body?==
==Do you need help in preparing your product and related documentation for a notified body?==