Is technical documentation required for the modernisation and modification of equipment?
EU Machinery Regulation 2023/1230 renders both ‘technical design documentation’ and ‘technical file’ obsolete and introduces the term ‘technical documentation’.
These documents must contain all the information that allows the manufacturer to demonstrate the product's compliance with the applicable requirements.
In practice, technical documentation must be compiled during the design and manufacture of the product and must be available to the competent market surveillance authorities after the product has been placed on the market. The requirement for the storage period of documents is generally quite extensive, as technical documentation must be kept at the disposal of the market surveillance authority for at least ten years from the date of placing the product on the market or putting it into service.
The technical documentation prepared by the manufacturer, or at least the documentation on the risk assessment carried out by the manufacturer at the design stage, will be necessary for subsequent upgrades to the machine or to improve its safety over time.
When assessing the significance of modifications to the machine in terms of safety, information on the initial situation is necessary, but this information partly overlaps with the information provided by the manufacturer with the machine when it was originally supplied. In turn, the initial information partly concerns documentation on changes that the machine owner may have made earlier during its life cycle and for which the person who made the changes is responsible, as well as information on the results of the assessment of occupational safety risks associated with the machine, for which the employer is responsible.
If significant changes are made to the machine, the situation as a whole changes, because when a new machine is created, we return to the starting point in terms of safety regulations. According to the Machinery Regulation, the person making significant changes to the equipment assumes the obligations and responsibilities of the manufacturer in the event of significant changes.