General
Products
which are to be provided with the CE marking shall be designed to
comply with relevant requirements.
Products
with the CE marking shall be produced in accordance with the
design that was found to comply with relevant requirements.
This
leaflet provides information about the "Declaration of
Conformity", which is an official statement that a product
is in conformance with an approved design.
The
"Technical Construction File" is the basis of the conformity
assessment of the design. A separate information leaflet on this
file is available here.
The
Declaration
Essentially
the declaration concerns an individual product. It shall state that the
product is in accordance with "Essential Requirements" of
applicable EU-directives. Several directives require that the
declaration is actually kept with individual products.
The
declaration shall identify the individual product and the requirements.
The declaration may refer to an "EC Type-examination
Certificate" issued by a Notified Body in the design-stage.
Administration
of the declaration
In
principle, a declaration shall be available for each individual product.
In case of series-production and production of (large) numbers of
identical products, the declaration may apply to lots or batches of
products. The marking of the products (by serial-numbers, date-codes,
etc.) and the registration-indications of the declarations shall clearly
refer to each other.
Governmental
authorities and Notified Bodies will require insight in the
administration system of the manufacturer. Upon their request, the
declaration concerning a certain product, shall be made available on
short notice.
Notified
Body
All
modules (except Module A) of the conformity assessment scheme require
the involvement of a Notified Body in the production-stage. It is the
obligation of the Notified Body to verify the declarations and to repeat
evaluations and tests if considered necessary.
Information
For
further information please contact:
CEBEC
Avenue. Fr. Van Kalken 9A, b. 1
B-1070 Brussels (Belgium)
Phone: +32 2 556 00 20
Fax: +32 2 556 00 36
CEBEC provides market access
|
