arpadveress ANNEX X
EU DECLARATION OF CONFORMITY (No XXXX) (1) 1. Product model/product (product, type, batch or serial number):
2. Name and address of the manufacturer and, where applicable, his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the declaration (identification of product allowing traceability; it may, where necessary for the identification of the product, include an image):
5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:
6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:
7. Where applicable, the notified body … (name, number) performed … (description of intervention) and issued the certificate:
8. Additional information: Signed for and on behalf of: (place and date of issue): (name, function) (signature):
__________
(1) It is optional for the manufacturer to assign a number to the declaration of conformity. § 227 The EU declaration of conformity
The EU declaration of conformity, to be drafted and signed by the manufacturer, is required by Article 14 of the ATEX Directive 2014/34/EU (see section § 93).
Annex X includes a model structure for the EU declaration of conformity, based on Annex III to the Decision No 768/2008/EC.
Brief comments for each point of the model for the EU declaration of conformity are shown in Table 8: EU declaration of conformity below.
EU DECLARATION OF CONFORMITY (No XXXX)
Heading of the EU declaration of conformity. The manufacturer is not required to assign a number but it could be useful for traceability purposes.
1. Product model / product (product, type, batch or serial number)
This point should reflect the unique identification of the product.
2. Name and address of the manufacturer and, where applicable, his authorised representative
Straightforward, noting that the name (and/or the identification mark) on the product places the named organisation in the position of manufacturer (or his authorised representative in the European Union).
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.
Reaffirming the overall responsibility of the manufacturer on the product to be placed or put into service on the EU market.
4. Object of the declaration (identification of product allowing traceability; it may, where necessary for the identification of the product, include an image)
This includes the description of the concerned product: it could be 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.
Indication of all relevant provisions fulfilled by the equipment would include the markings affixed on the product, e.g. equipment group II, category 2 G (IIB T4).
5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation
The references of the legislative acts (Regulations or Directives) to which conformity of the product is declared.
If it is a multi-directive declaration, it should already be clear from the heading which directives the product conforms to.
It is sufficient to indicate the codification or numbering of the legislative act (e.g. “Directive 2014/34/EU”, “Directive 2006/42/EC”, etc.) with no need to indicate the complete title and the publication references according to Article 14.3.
6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared
The European harmonised standards quoted in the technical documentation file shall be indicated here. They should be indicated as listed in the relevant publication in the Official Journal of the European Union, being sufficient to indicate the number and the year of publication (e.g. “EN 1010- 1:2004+A1:2010”, “EN 60079-0:2012”, etc.) and not by the national editions (BS, DIN, NF, UNI, UNE etc.), also taking into consideration that the year could be different.
Where appropriate, other standards and/or technical specification used, as quoted in the technical documentation, should be indicated here, along with the justification for the use of a non-harmonised standard. For standards that were harmonised but have now been superseded, the justification should be in line with the Clarification Sheet ExNB/10/397/CS issued by the European Coordination of ATEX Notified Bodies Group (ExNBG), available on http://ec.europa.eu/DocsRoom/documents/9568/attachments /1/translations/en/renditions/native.
7. Where applicable, the
Name and number of the notified body (or bodies) conducting notified body … (name, number) performed … (description of intervention) and issued the certificate the EU-type examination. Indication of the notified body’s identification number, when applicable (where involved in the production phase) can be seen as a support to market surveillance actions.
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. However, the name and address of a notified body involved in the production phase is not a mandatory requirement.
There shall be no reference to a notified body certificate unless it is one coming within the scope of the Directive. Voluntary 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. 8. Additional information Any other additional information that could be considered relevant for the declaration. Signed for and on behalf of: (place and date of issue) (name, function) (signature) Identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer. The signatory needs to be a responsible officer of the manufacturer or of the authorised representative.
