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A CoC or EC Certificate of Conformity is equal to a declaration of the conformity with the type approval of EC. It is produced to ensure the free movement of equipment within the European Union, specifically for equipment that is subject to homologation or registration.
The manufacturer draws up an EU declaration of conformity or a declaration of performance (for Construction Products) and affixes the CE marking on the product. If stipulated in the directive(s) or regulation(s), an authorized third party ( Notified Body ) must be involved in the conformity assessment procedure or in setting up a production ...
An authorised representative may also carry out a conformity assessment of a medical device on behalf of the manufacturer. [ 7 ] European ‘Blue Guide" [ 8 ] describes that delegation of an authorised representative should be set out in writing (as an agreement, mandate, or power of attorney) to define contents and limits of tasks.
Records must be kept for all equipment. All equipment manufactured should be given a “birth certificate”. This should prove that when first made, it complied with any requirement. In Europe today, this document would normally be an EC Declaration of conformity plus a manufacturers certificate if called for by the standard worked to.
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.
The CE logo now indicates compliance and RoHS 2 declaration of conformity is now detailed (see below). [ citation needed ] In 2012, a final report from the European Commission revealed that some EU Member States considered all toys under the scope of the primary RoHS 1 Directive 2002/95/EC, irrespective of whether their primary or secondary ...
Harmonised standards for Directive 94/25/EC are developed at international level by the International Organization for Standardization in the ISO Technical Committee 188 and CEN. Products which fulfil the Directive's essential requirements must bear the CE marking of conformity. The CE marking must appear in a visible, legible and indelible ...
Following type approval, a vehicle is issued with a Certificate of Conformity which includes a COC number. This number may look like: e13*2001/116*0260 where e13 is the UNECE state number (in this case Luxembourg), 2001/116 is the EC/EU directive name.
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