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Declarations of Conformity |
The preparation and issuing of these is a prerequisite for any product that requires CE marking for sale and use within the European Union. This procedure confirms that the manufacturer believes that the manufactured product meets the Essential Requirements of all applicable Directives.
The Declaration of Conformity (DoC) must contain: - The name and address of the manufacturer or representative
- Product description
- Directive(s) with which compliance is declared
- Harmonised standards applied
- Additional standards and specifications used (if applicable)
- Place and date of issue
- Name and signature of person authorised by the manufacturer to make the declaration
DoC's must be kept on file for issue in the EU. Manufacturers may also provide copies with each product or shipment, and for machines a DoC or Declaration of Incorporation (for machines intended to be incorporated with other machines) is required for each machine. Depending on the product type the following steps maybe required: - Preparation of technical documentation demonstrating compliance
- Documentation of the manufacturer's Quality Management System
- Application for assessment of Quality System
- Audit of the Quality System by a Notified Body
- Application for an EC Type Examination of the product's design
- Continued surveillance by the Notified Body
- Any additional (post production) requirements
Eurolink (Europe) is well placed to assist you in all aspects of meeting these requirements. For further information please contact us.
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