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 signed
declaration of conformity, Instruction booklet for safe use and maintenance.
NOTE:
High risk products cannot be self certified
Higher risk products will also call for implementation and certification of the designated Quality Management System.
You cannot CE Mark your product, if there are no applicable Directives for your product. General Product Safety Directive is not to be counted
Process of CE Marking ( third party-certification mode )
The steps essentially remain the same.
In this case, the test must be witnessed by a Notified Body.
The test report will be made by the Testing Laboratory, and declaration will be made by the Notified Body.
The CE Mark will carry a number linking to the Notified Body.
DISCLAIMER: This matter is reproduced here as a guide only. For authentic and up-to-date information,
please contact the Notified Body.