This Regulation sets out:
- The risk assessment process to be applied in case of technical, operational or organisational changes;
- The criteria to be fulfilled by the assessment body responsible for checking the correct application of the risk assessment process and the results of this application, and the necessary requirements for the accreditation or recognition of its competence in order to achieve a similar quality of independent assessment;
- The harmonised design targets for technical systems which should help with mutual recognition of those systems across the European Union.
It applies to the proposer as defined in Article 3(11) of Regulation (EU) No 402/2013 when making any change to the railway system in a Member State.