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Regulations
Where the equipment is supplied for assembly with other items to form a complete machine at a later date, a DECLARATION OF INCORPORATION should be issued with it. The CE mark should not be applied. The declaration should state that the equipment must not be put into service until the machine into which it has been incorporated has been declared in conformity. A Technical File must be prepared and the partly completed machinery must be supplied with information containing a description of the conditions which must be met with a view to correct incorporation in the final machinery, so as not to compromise safety.
This option is not available for equipment which can function independently or which modifies the function of a machine.
The Declaration of Incorporation must contain the following information:
- Business name and full address of the manufacturer of the partly completed machinery and, where appropriate, the authorized representative;
- Name and address of the person authorized to compile the relevant technical documentation, who must be established in the Community (in the case of a manufacturer outside the EU this may be the Authorized Representative);
- Description and identification of the partly completed machinery including generic denomination, function, model, type, serial number and commercial name;
- A sentence declaring which essential requirements of this Directive are applied and fulfilled and that the relevant technical documentation is compiled in accordance with part B of Annex VII, and, where appropriate, a sentence declaring the conformity of the partly completed machinery with other relevant Directives;
- An undertaking to transmit, in response to a reasoned request by the national authorities, relevant information on the partly completed machinery. This shall include the method of transmission and shall be without prejudice to the intellectual property rights of the manufacturer of the partly completed machinery;
- A statement that the partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the provisions of this Directive, where appropriate;
- The place and date of the declaration;
- The identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or the authorized representative.
