The technical documentation must permit the assessment of the conformity of the apparatus with the essential requirements and demonstrate its conformity with the said requirements. The manufacturer draws up the technical documentation before the apparatus is placed on the market and is responsible for keeping it up to date. The technical documentation must cover the design, manufacture and operation of the apparatus. Depending on the procedure applied, the manufacturer will have to include in the technical documentation an adequate analysis and assessment of risks, though this is advised in all cases.
The technical documentation shall comprise:
- a general description of the apparatus;
- design and production drawings together with schedules of components, sub-assemblies, circuits, etc.;
- the descriptions and explanations necessary to understand these drawings and schedules as well as the operation of the apparatus;
- a list of the technical standards referred to in Art. 5, applied in whole or in part and, when these standards have not been applied, a description of the solutions adopted to comply with the essential requirements of this ordinance, including a list of the other pertinent technical specifications applied; in the event of partial application of the technical standards referred to in Art. 5, the technical documentation specifies the parts applied;
- the results of the design calculations, the checks which have been carried out, etc.;
- an adequate analysis and assessment of the risk or risks when the manufacturer implements the Module B procedure (Annex 3);
- the test reports.
If the technical documentation is not written in one of the official languages of Switzerland or in English, OFCOM may require the complete or partial translation thereof into one of the above-mentioned languages.
The manufacturer, its agent, or if none of these two persons is based in Switzerland, the importer, must be able to present a copy of the technical documentation at OFCOM's request within a reasonable time (normally 10 working days). This technical documentation must be archived for ten years from the date of placing on the market. In the event that series of apparatus are placed on the market, this period runs from the date the last apparatus item in the series concerned was placed on the market.