Scope
Article 2
1. This Regulation shall apply to the proposer as defined in Article 3(11) when making any change to the railway system in a Member State. Such changes may be of a technical, operational or organisational nature. As regards organisational changes, only those changes which could impact the operational or maintenance processes shall be subjected to consideration under the rules of Article 4. 2. When, on the basis of an assessment under the criteria set out in Article 4(2)(a) to (f): (a) the change is considered significant, the risk management process set out in Article 5 shall be applied; (b) the change is considered not significant, keeping adequate documentation to justify the decision shall be sufficient. 3. This Regulation shall apply also to structural sub-systems to which Directive 2008/57/EC applies: (a) if a risk assessment is required by the relevant technical specification for interoperability (TSI); in this case the TSI shall, where appropriate, specify which parts of this Regulation apply; (b) if the change is significant as set out in Article 4(2), the risk management process set out in Article 5 shall be applied within the placing in service of structural sub-systems to ensure their safe integration into an existing system, by virtue of Article 15(1) of Directive 2008/57/EC. 4. The application of this Regulation in the case referred to in paragraph 3(b) of this Article shall not lead to requirements contradictory to those laid down in the relevant TSIs. If such contradictions occur, the proposer shall inform the Member State concerned which may then decide to ask for a revision of the TSI in accordance with Article 6(2) or Article 7 of Directive 2008/57/EC or a derogation in accordance with Article 9(2) of that Directive. 5. The railway systems excluded from the scope of Directive 2004/49/EC according to its Article 2(2) are excluded from the scope of this Regulation. 6. The provisions of Regulation (EC) No 352/2009 shall continue to apply in relation to projects which are at an advanced stage of development within the meaning of Article 2(t) of Directive 2008/57/EC at the date of application of this Regulation.