Substantial modification
Modification of machinery, physical or digital, that creates a new hazard or increases an existing risk, thereby transferring manufacturer status to whoever performs it.
The European machinery regulation defines the notion and draws a heavy consequence from it: whoever modifies a machine in a way that creates a new hazard becomes the manufacturer of the modified machine, with the full set of corresponding obligations, conformity assessment, technical file, declaration and marking. The rule existed in substance under the earlier regime, it is now defined, and above all it expressly covers digital modifications as much as physical ones. The difficulty lies in applying it to a learning system: does training a robot on a new task, loading a control policy supplied by a third party or permitting continuous learning in operation amount to substantial modification? The criterion supplied, the emergence of a new hazard, presupposes knowing what the machine will do afterwards, which is precisely indeterminate.
No general liability policy was drafted for that position, and the relevant cover becomes product liability, which many machine users have never bought because they manufacture nothing.
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