The technical file to be issued in compliance with the PED directive is drawn up according to the category to which the equipment belongs. Different modules are therefore available to choose from and the choice also depends on the tasks to be performed by the notified body.
The file must make it possible to assess the conformity of the pressure equipment with the applicable requirements of the directive; it must therefore include - to the extent necessary for such assessment- design, manufacturing and operation information with regard to the pressure equipment and contain as minimum requirement:
- a general description of the product;
- design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc;
- descriptions and explanations necessary for the understanding of said drawings and diagrams and the operation of the pressure equipment;
- a list of the harmonised standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where these standards have not been applied;
- the results of design calculations made and testing carried out, etc.;
- test reports;
- information concerning the tests performed as to the manufacture of the product; information concerning the qualifications or approvals required and in accordance with points 3.1.2 (joints) and 3.1.3 (non-destructive tests) of Annex I;
- the necessary references and objective evidence of the quality management system adopted.