Application of EU implementation regulation 402/2013


The implementing regulation 402/2013 concerning railway safety within the European Union, aims at the uniformity in all Member States of a common application of safety management, evaluation and control of risk against changes in:

  • operating conditions,
  • technical changes (in infrastructure or rolling stock, for instance),
  • organizational changes within railway administration.

The regulation, which is mandatory, identifies the changes to be implemented as significant or non-significant. In each case, it should apply a set of activities to demonstrate that the rail system continues to respect the safety requirements it had before the change carried out.

In addition, strategies for acceptability of the risk of a significant change are presented: via the application of practical codes, comparing similar parts of the rail system or through an explicit risk estimation.


On the other hand and as a tool that we consider very interesting in Leedeo Engineering, it also introduces tools to qualitatively value the importance of change, taking into account the following criteria:

  1. Consequences in case of failure,
  2. Innovation used in the realization of change,
  3. Complexity of change,
  4. Ability or inability to monitor the change,
  5. Predictability,
  6. Additionality, that is to say, relativizing change, considering all recent modifications related to safety of the system evaluated.

Leedeo is an expert in the development of studies and safety reports of railway RAMS. We are supporting the best companies in the sector in developing safety studies of their projects and works to comply with Regulation (EU) No 402/2013. Turnkey. We manage every RAMS activity of our clients' projects.

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