Recital (26)

In order to ensure that machinery or related products, when placed on the market or put into service, do not entail health and safety risks for persons or domestic animals and do not cause harm to property, and, where applicable, to the environment, essential health and safety requirements should be set out which have to be met in order for the machinery or related products to be allowed on the market. Machinery or related products should comply with the essential health and safety requirements when placed on the market or put into service. Where such products are subsequently modified, by physical or digital means, in a way that is not foreseen or planned by the manufacturer and which affects the safety of such products by creating a new hazard or increasing an existing risk, the modification should be considered as substantial when new significant protective measures are required. However, repair and maintenance operations which do not affect the machinery or related product’s compliance with the relevant essential health and safety requirements should not be considered to be substantial modifications. In order to ensure the compliance of such a product with the relevant essential health and safety requirements, the person that carries out the substantial modification should be required to perform a new conformity assessment before placing the modified product on the market or putting it into service. In order to avoid an unnecessary and disproportionate burden, the person carrying out the substantial modification should not be required to repeat tests and produce new documentation in relation to machinery or related products that are part of an assembly of machinery, and that are not affected by the modification.