The EC declaration of conformity is the written statement and the a single declaration drawn up by the manufacturer to demonstrate the fulfilment of the EU requirements relating to a product bearing the CE marking he has manufactured.
A Notified Body does not issue a DOC. It issues a certificate of conformity or similar document stating that it believes that the equipment and the documentation that accompanies it are in conformity with the requirements of a directive based on examination of a technical file. It makes no guarantee that the equipment that the manufacturer actually places on the market is in conformity with the directive. The DOC is issued by the manufacturer to accompany each item they sell. It declares that they guarantee that each piece of equipment sold is in conformity with the Directive(s) mentioned.
A DOC can cover one directive or several directives. Where equipment is covered by several directives, e.g. MD, LVD, EMC, PED it can be covered by one DOC that covers the requirements of all the directives or by several different DOCs that each cover one or more directives.
Each piece of equipment placed on the market must be accompanied by DOCs covering the relevant directives. The DOC could be on a separate sheet, but a good place for it is in the operation manual.
The basic requirements for all DOCs are:-
1. Identify the directive(s) with which conformity is claimed.
2. Identify the manufacturer of the equipment.
3. Identify any European representative of the manufacturer.
4. Identify any EN harmonised standards used.
5. Signed and dated by a person with enough responsibility to ensure that the Declaration is true, for example a Director or Chief Engineer.
EUROPEAN DECLARATION OF CONFORMITY
We, (Company name, Address, Phone, FAX) declare under our sole responsibility that the product
(name, type or model, lot, batch or serial number, possibly sources and numbers of items)
to which this declaration relates is in conformity with the following standard(s) or other normative document(s)
(title and/or number and date of issue of the standard(s) or other normative document(s)
(if applicable) following the provisions of
Directive(s). (Machinery, Electromagnetic Compatibility, etc.)
The Technical Construction File is maintained at: (give the address of the facility where the File is maintained).
The authorized representative located within the Community is:
(name, address, phone, FAX)
NOTE: The authorized representative must be located within one of the member states of the European Union.
Per Annex II.B of the Machinery Directive (98/37/EC):
The machinery, product, assembly or sub-assembly covered by this Declaration of Conformity must not be put into service until the machinery into which it is to be incorporated has been declared in conformity with the provisions of the applicable Directive(s). This statement is only necessary where the product is to be incorporated into a machine or system (e.g. a safety component).
Date of issue: Place of issue: (Signature of authorized person) (Typed name of authorized person)