 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 "Technical Construction
File" which is the basis of the conformity assessment of the design.
For
each product with the CE marking the manufacturer shall issue a
"Declaration of Conformity"; this document states that the product
is in conformance with the approved design. A separate information
leaflet on this declaration is available.
The File
Essentially
the file shall provide the necessary evidence that the design is in
accordance with relevant requirements.
The
file shall identify the product and the requirements. It shall describe
the assessment-activities, and contain the results of these activities.
Suggestions
for file-elements are:
*
Name of the company responsible for the design,
*
Name and function of the employee responsible for the file,
*
Name (of the product),
*
Type-designation,
*
Description:
- photographs,
brochures,
-
technical construction drawings,
-
material compositions,
-
schematic diagrams,
-
parts lists of components,
-
descriptions of components,
all different versions shall be described, as far as relevant,
*
Copies of the users manual and service instructions, as far as
applicable,
*
List of applicable EU-directives,
*
List of normative technical documents or standards used for the
conformity assessment,
*
Design calculations,
*
Hazard analysis,
*
Description of measures to reduce or eliminate hazards,
*
Evaluation- and test-reports, indicating:
-
which evaluations and tests were performed,
-
methods of evaluations and tests,
-
evaluation- and test-equipment,
-
results of evaluations and tests,
-
acceptance criteria.
*
Conclusion, indicating that the product complies with all
relevant requirements.
If considered
appropriate, descriptions and explanations to properly understand the
documents, shall be provided.
It
is the responsability of the manufacturer to decide about the assembly
of the file.
Information
sources
The
manufacturer may use outside-sources for the file or sub-contract the
file, in parts or completely.
Manufacturers
may not have available all evaluation- and test-equipment as required by
the technical standards. Specialized laboratories, like CEBEC, provide
relevant evaluation- and testing services.
In
all cases the manufacturer remains responsable for the contents of the
file and should operate an adequate system to verify the contents of
information received. This verification can be asked from third-party
certification institutes or Notified Bodies, like CEBEC.
Administration
of the file
The
file-elements need to be available. It is not an absolute requirement
that the file is available as a "physical" entity.
Manufacturers
usually operate quality management systems or administration systems
with document control procedures. The file-elements can be made
available in accordance with these procedures.
Authorities
and Notified Bodies will require insight in the administration system of
the manufacturer. Upon their request, the file, as a
"physical" entity, shall be made available on short notice (a
few days).
Notified Body
Modules
Aa, B and H, of the conformity assessment scheme, require the
involvement of a Notified Body in the design-stage. It is the obligation
of the Notified Body to verify the contents of the file 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
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