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.
High risk
products cannot be self certified
Higher
risk products will also call for
implementation and certification of the
designated
Quality Management System.
