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Process of CE Marking ( self-certification mode )
1. Study which directive/s is applicable 2. Determine which standard/s are applicable 3. Test your product to ascertain if it complies 4. Make a test report 5. Make Technical Construction File: Technical documentation - The manufacturer
must draw up a technical Construction file
(TCF). The technical documentation is
intended to provide information on the
design, manufacture and operation of the
product.
6. Prepare a technical file documenting compliance with the applicable requirements. 7. Prepare and sign a manufacturer’s self-declaration of conformity. 8. Apply the CE Mark to the product. 9. Ship the product to the European Union with a copy of the Signeddeclaration of conformity. NOTE: High risk
products cannot be self certified
Higher
risk products will also call for
implementation and certification of the
designated
Quality Management System.
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