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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:
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:
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.
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.