Machine Manufacturing
Substantially Modified Machinery: CE Marking and Manufacturer Responsibility
Machinery is often modified during its lifetime, for example when components are replaced or when its function or application changes. But not every modification has the same consequences under the Machinery Regulation (EU) 2023/1230.
If a modification affects machinery safety and meets the criteria for a substantial modification, responsibility can shift from the original manufacturer to the person or company carrying out the change. This can mean that the modified machinery needs to undergo a new conformity assessment, with a new Declaration of Conformity and CE marking.
What is a substantial modification?
A substantial modification is a physical or digital change made to machinery after it has been placed on the market or put into service. The change must not have been foreseen or planned by the original manufacturer and must affect the safety of the machinery by creating a new hazard or increasing an existing risk.
Whether the modification is substantial also depends on the protective measures required as a result of the change. The modification is considered ”substantial” if it includes additional guards or protective devices requiring changes to the existing safety-related control system, or when additional measures are needed to ensure stability or mechanical strength.
Not every modification therefore results in new manufacturer responsibilities. The modification needs to be assessed against these criteria before determining what requirements apply.
Modification or maintenance: where is the line?
Not every change to machinery is a substantial modification. Maintenance and repair can involve replacing parts without changing the machinery in a way that affects its safety or creates new manufacturer responsibilities.
For example, replacing a safety-related component with an identical or functionally identical component is not considered a substantial modification. The situation is different if a change creates a new hazard or increases an existing risk. In that case, the modification needs to be assessed to determine whether it meets the criteria for a substantial modification.
Checklist: Have you become a manufacturer?
When machinery is modified, the change needs to be assessed to determine whether it is considered a substantial modification. Taken together, these questions help determine whether the change meets the criteria for a substantial modification and whether manufacturer responsibilities apply.
The assessment can be structured around five questions:
What happens if the modification is substantial?
If a modification is considered substantial, the person or company carrying it out takes on the responsibilities of the manufacturer. This may be the customer or a company contracted to carry out the modification, rather than the original manufacturer.
The modified machinery must then undergo the applicable conformity assessment process. This includes preparing the required documentation, issuing a new Declaration of Conformity and CE marking the machinery before it is placed on the market or put into service again.
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