Substantial modification: when whoever modifies a machine becomes its manufacturer

According to the sources we consulted, it is a modification:

• physical or digital, so a software update counts too;
• not foreseen by the original manufacturer;
• made after placing on the market or putting into service;
• that creates a new hazard or increases an existing risk, making new protective measures necessary.

What is new compared with the Directive is that the definition is written into the Regulation and explicitly includes digital modifications.

• Integrators who combine several machines or partly completed machines into a line.
• Retrofit companies that modernise existing machinery.
• Users who modify a machine in-house, for example by changing guards or safety logic.
• Whoever updates software that affects safety functions.

Whoever makes a substantial modification takes on the obligations of the manufacturer, for the modified part or for the whole machine if the modification affects all of it: risk assessment, technical documentation, updated instructions, declaration and marking. It is always worth assessing the case with a CE consultant.

When a machine is modified years after sale, the first question is: what was originally delivered? Having for each serial number the version of the manual, the configuration and the history of the safety software helps both the original manufacturer and whoever modifies it to separate responsibilities.

In TARGA every serial number has its publication and software history, and the manufacturer chain links later incorporations and substantial modifications.