1.Implementing rules for interoperability shall be drawn up whenever necessary to achieve in a coherent way the objectives of this Regulation.
2.Systems, constituents and associated procedures shall comply with the relevant implementing rules for interoperability throughout their lifecycle.
3.Implementing rules for interoperability shall in particular: (a) determine any specific requirements that complement or refine the essential requirements, in particular in terms of safety, seamless operation and performance; and/or (b) describe, where appropriate, any specific requirements that complement or refine the essential requirements, in particular regarding the coordinated introduction of new, agreed and validated concepts of operation or technologies; and/or (c) determine the constituents when dealing with systems; and/or (d) describe the specific conformity assessment procedures involving, where appropriate, notified bodies as referred to in Article 8, based on the modules defined in Decision 93/465/EEC to be used to assess either the conformity or the suitability for use of constituents as well as the verification of systems; and/or (e) specify the conditions of implementation including, where appropriate, the date by which all relevant stakeholders are required to comply with them.
4.The preparation, adoption and review of implementing rules for interoperability shall take into account the estimated costs and benefits of technical solutions by means of which they may be complied with, with a view to defining the most viable solution, having due regard to the maintenance of an agreed high level of safety. An assessment of the costs and benefits of those solutions for all stakeholders concerned shall be attached to each draft implementing rule for interoperability.
5.Implementing rules for interoperability shall be established in accordance with the procedure under Article 8 of the framework Regulation.