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.
Essential criterion has 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.
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.
Note: 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.