PLATE 07 OF 20
Substantial modification.
When a change to machinery already placed on the market creates new manufacturer obligations.
Pillar guide
Substantial modification: review the change, not its label: The Regulation defines a specific physical or digital change test. “Retrofit” alone does not determine the legal outcome.
Supporting guides
| Guide | What it covers |
|---|---|
| The substantial modification test step by step | Each element of Article 3(16), in order, so no criterion is skipped in a project review. |
| Foreseen and planned changes | What counts as foreseen or planned by the manufacturer, and how the original design record proves it. |
| Software changes as modifications | A software change can be a substantial modification, and the test is the same: hazard, risk, and the additional criterion. |
| Retrofits and the modification test | Why retrofit alone does not determine the outcome, and what a retrofit review must examine. |
| Modification of part of an assembly | Where only a product within an assembly is affected, the limitation must be demonstrated by risk assessment. |
| The non professional own use exception | Article 18 excepts a non professional user modifying their own machinery for their own use, and no further. |
| Maintenance versus modification | Maintenance that keeps a machine in its assessed state, against a change that creates a new hazard or increases a risk. |
| Modifications before the Regulation applies | Changes to machinery under the current Directive framework, and why the Regulation definition cannot simply be backdated. |