The ‘Declaration of Conformity’ is perhaps the most important document in ATEX, it is what legally makes equipment ‘ATEX’ under the CE Marking Directive. Once the manufacturer has undertaken the appropriate procedures to assure conformity with essential requirements of the Directive it is the responsibility of the manufacturer or his authorised representative established in the EU to affix the CE marking and to draw up a written EC Declaration of Conformity.
Note: Where neither the manufacturer nor his authorised representative is established within the EU, the obligation to keep the copy of the EC Declaration of Conformity available is the responsibility of the person who places the product on the EU market.
In respect of the Notified Bodies possibly involved in the conformity assessment procedure (for example, electrical equipment of categories 1 or 2 and non-electrical equipment category 1) the EC Declaration of Conformity must contain, where appropriate, the name, identification number and address of the Notified Body and the number of the EC-Type Examination Certificate. The name and address of a Notified Body involved in the production phase, where relevant, is not a mandatory requirement.
Declaration of Conformity for Assemblies under ATEX
As far as assemblies of ATEX equipment are concerned, if an assembly is to be treated as a new item of ATEX equipment the EC Declaration of Conformity needs only to identify the unit and the related information.
Details of the items of equipment making up the assembly will be included on the technical file. However, there is a duty on all those in the supply chain to pass on the relevant information relating to the items of equipment where these have been previously placed on the market accompanied by their own EC Declaration of Conformity and instructions.
As a general rule, the content of the Declaration of Conformity contains the following:
|Name or identification mark and address of the manufacturer or his authorised representative in the European Union||The name on the product places the named organisation in the position of manufacturer (or authorised representative).|
|A description of the equipment, etc. A descriptive product designation e.g. Motor Control Unit Type ABC 123 and its intended use.||For an assembly it should list the items in the assembly that are ATEX equipment in their own right, and which have been separately assessed.|
|All relevant provisions fulfilled by the equipment and the marking included on the product||e.g. Equipment Group II, category 2 G II B T4 etc.|
|Where appropriate, the name,identification number and address of the Notified Body and the number of the EC-Type Examination Certificate Name and number of the Notified Body (or Bodies)conducting the EC-type examination if applicable.
In the case of Category 2 non-electrical equipment, it should refer to the Notified Body holding the copy of the technical documentation file.
|Where relevant, if the body responsible for oversight of the QA regime is not the same as the one issuing the original certificate, it should be named separately. There shall be no reference to a Notified Body certificate unless it is one coming within the scope of the Directive. Certificates issued by bodies in their “private” capacity as certification bodies should be included in the technical documentation file as part of the evidence of conformity but should not be quoted on the declaration of conformity.|
|Where appropriate, reference to the harmonized standards||The harmonised standards quoted in the technical documentation file should be listed here.|
|Other non- harmonized standards||Other standards and technical specifications quoted in the technical documentation file should be listed here|
|Where appropriate, references to other EU Directives which have been applied||If this is a multi-directive declaration, it should already be clear from the heading which directives the product conforms to.|
|Identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer, etc.||The signatory needs to be a responsible officer of the manufacturer or of the authorised representative.|