Presumption of conformity can only be obtained if the harmonized standard is complied with.

According to EN ISO 12100, risk assessment included in the safety design of machinery should not be a one-off process carried out only during the initial design of a given type of machinery, but should be reviewed at regular intervals throughout the production period of the type of machinery in question. During such a risk assessment, the manufacturer may use feedback from the operation of this type of machinery (possible accidents and other data) and assess whether, based on technical progress, changes should be made to the type of machinery to improve safety, i.e. whether the essential requirements of Annex I need to be applied in a new way. One of the most important indicators of technical progress is harmonized standards for machinery, the requirements of which are usually increased over time.

Presumption of conformity can only be obtained if the harmonized standard is complied with.