CE Marking
CE Marking
CE Marking
CE Marking:
Format and Contents of the Technical File
Before issuing an EC declaration of conformity for machinery it is essential that the
manufacturer or his authorized representative established in the European Community
provides a technical construction 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 obligation to provide information
in the technical file required by the machinery directive 89/392/EEC.
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 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:
o the name and the address of the manufacturer and the identification of the
product;
o the list of harmonized standards followed by the manufacturer and/or the
solutions adopted to satisfy the essential requirements;
o a description of the product; the operating instructions,
o 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.