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The following technical file procedures refer only to procedures
set forth in the directives that do not require intervention by
notified bodies.
Most of the new approach directives impose an obligation for the
manufacturer to draw up and to provide technical documentation
(or a technical file) containing certain information to
demonstrate the conformity of the product to the requirements of
the directive.
Although each directive specifies the content of the technical
file, further details concerning the extent, content and form of
the information supplied are needed to ensure better
exploitation of the technical file by the national inspection
authorities and to facilitate the manufacturer's task at the
drafting stage.
Format and Contents of the Technical File
In Decision 90/683/EEC of 13 December 1990 the Council
established that "the essential objective of a conformity
assessment procedure is to enable the public authorities to
ensure that products placed on the market conform to the
requirements as expressed in the provisions of the directives,
in particular with regard to the health and safety of users and
consumers".
This guideline from the Council is, therefore, the essential
criterion to be taken into account when considering the content
and extent of the information to be supplied in the technical
file provided for in the directives, i.e. the content and extent
of the obligation to provide information.
Consequently, the details included in the technical file always
depend on the nature of the product and on what is necessary,
from the technical point of view, to demonstrate the conformity
of the product either to the harmonized standards, if the
manufacturer has followed them, or to the essential requirements
of the relevant directive if the manufacturer has followed none
or only some of the harmonized standards. This must, therefore,
be determined case by case depending on the product.
To allow effective exploitation of this file for market
surveillance purposes, excessive paperwork should be avoided. To
achieve this and to facilitate the manufacturers' task, it is
proposed that the inspection authorities should accept
subdivision of the file into two parts.
1. The first part (A) would consist of a summary of the
essential technical data relevant to the conformity assessment
procedures, including in particular:
the name and the address of the
manufacturer and the identification of the product;
the list of harmonized standards
followed by the manufacturer and/or the solutions adopted to
satisfy the essential requirements;
a description of the product;
the operating instructions, if any;
the overall plan of the product, if
any.
2. The second part (B) would consist of a full file containing
all the test reports, information concerning the quality manual,
plans, descriptions of the products and processes, standards
applied, etc.
If the manufacturer fails to follow this two-part breakdown of
the technical file, the inspection authorities could demand the
full technical file or part thereof according to the
requirements for inspection purposes, unless the details given
in the declaration of conformity or in the certificate of
conformity appear sufficient for the purposes of conducting a
preliminary inspection.
Availability of the Technical File
The technical file must be kept at the disposal of the national
authorities for inspection and control purposes. With certain
exceptions, this obligation to keep at least one technical file
inside the territory of the Community starts at the time of the
placing the product on the Community market whatever the
geographical origin of the product.
This obligation is incumbent upon the manufacturer or his
representative established in the Community.
If the manufacturer is not established in the Community and has
no representative in the Community, the person who places the
product on the Community market must take on this obligation.
Any person responsible for placing a product on the Community
market but not in possession of the technical file must be
capable of:
where the technical file is
situated inside the Community;
the technical file as soon as
possible on request from the national authorities.
However, the name and address of the person in possession of the
file need not be expressly mentioned on the product or on its
packaging, unless otherwise specified.
The file cannot be requested systematically. In general, it can
be requested only during checks made for market surveillance
purposes by the Member States.
In any event the request for the technical file must remain in
proportion to the requirements of the inspection carried out.
Therefore in general the manufacturer or person responsible for
placing a product on the Community market should initially
provide the inspection authorities with only a summary of the
essential technical data (part A of the technical file). One or
more specific points of the second part can nevertheless be
requested in cases of serious doubt about the conformity of the
product to the Community regulations.
The full technical file can only reasonably be requested where
necessary and certainly not when only an individual point is to
be checked, in which case only the relevant part of the file
should be required.
If the competent authorities in the Member State request the
technical file, the first part of the technical file (part A)
should be made available immediately, allowing a reasonable time
for transmission. Extra time should be granted for submission of
the second part (part B) of the file, taking into account its
volume and form (written, computerized...).
Community-wide organization of the market surveillance
procedures and coordination of the inspections should avoid
repeated submission of the same technical file by the same
manufacturer to different inspection authorities. The technical
file must be kept for at least ten years from the last date of
manufacture of the product, unless the directive expressly
provides for any other duration.
Language of the Technical File
If the Community directives contain no specific provisions
concerning the language of the file, the requirements of the
Member States must be assessed on the basis of Article 30 of the
EEC Treaty on a case by case basis, taking into consideration
the proportionality of their demands. A Member State may request
presentation of the first part of the technical file (part A) in
its official language but should not do so if the national
authorities can understand the file or its contents in the other
language. Where a translation is required the person in
possession of the file will be allowed extra time to submit the
first part of the file to the inspection authorities.
Moreover, no further conditions may be imposed concerning this
translation, such as a requirement of a translator accredited or
recognized by the public authorities, or of official translators
or other similar requirements.
Confidentiality
Decision 90/683/EEC (Annex I.i) stresses the need to ensure the
legal protection of confidential information. No exceptions can
be made to this very important principle which the Member States
must observe strictly. To this end, Member States must ensure
that everyone involved in the assessments, inspections and
surveillance and who has knowledge of the contents of the
technical file is bound to professional secrecy.
Precise rules will, where necessary, have to be laid down by the
Member States to guarantee this confidentiality. This applies in
particular to the bodies notified by the Member States, which
must ensure that these bodies maintain this confidentiality.
Confidentiality is also mentioned in the EN 45000 series of
standards which serve as the reference standards for the
notification of bodies by the Member States.
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