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Self-DeclarationIf a machine is not on the products list in Annex IV, the only option available to demonstrate compliance with the MD is self-declaration. In other words, the manufacturers' Declaration of Conformity is not required to be based on third-party intervention. However, most manufacturers desire some sort of involvement by an outside agency who is familiar with the European compliance system. As with the Low Voltage and EMC Directives, when self-declaring compliance with the MD, the manufacturer verifies safe design by complying with the Essential Health and Safety Requirements. Safe design, combined with the appropriate production control and documentation, are the foundation for compliance with the directive. The manufacturer's visual demonstration of compliance (whether it is based on Notified Body intervention or self-declaration) is via the CE marking (as shown below) on the machinery and/or a Declaration issued by the manufacturer. |
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