The notified body shall be responsible for compiling the technical file that has to accompany the EC declaration of verification. The technical file must contain all the necessary documents relating to the characteristics of the subsystem and, where appropriate, all the documents certifying conformity of the constituents of interoperability. It must also contain all of the elements relating to the conditions and limits of use and to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance.
The Directive provides for infrastructure and rolling-stock meeting the requirements of interoperability to receive a two stage approval procedure, which once granted is challengeable only by specific appeal procedures. This obviously facilitates the work of the train operators who has only to obtain one technical approval to support operations in all Member States, although the final approval arrangements are expected to concern commercial and operating matters as well as technical ones. The first stage is called a Declaration of Conformity, and is obtained by the manufacturer of the equipment. It is essentially generic in nature and applies to the design and manufacturing process of a given constituent. The second stage is called a Declaration of Verification and is obtained when the subsystem is being commissioned. It is obtained by the project and addresses the details of the application. The Declaration of Conformity is generally awarded by a Notified Body, which is an independent test authority. Its role is to ensure that the requirements of annex A are respected. The Directive requires that a Declaration of Verification is always provided by a Notified Body.
