Technical documentation
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.
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