The quality of rail services in Europe depends, inter alia, on excellent compatibility between the characteristics of the network (in the broadest sense, i.e. the fixed parts of all the subsystems concerned) and those of the vehicles (including the onboard components of all the subsystems concerned). Performance levels, safety, quality of service and cost depend upon that compatibility.

For the purposes of this Directive, the system constituting the rail system may be broken down into the following subsystems, either:

1. (a)

   structural areas:

   • infrastructure,

   • energy,

   • control-command and signalling,

   • rolling stock;

2. (b)

   functional areas:

   • traffic operation and management,

   • maintenance,

   • telematics applications for passenger and freight services.

The ‘EC’ declaration covers:

• either the assessment by a notified body or bodies of the intrinsic conformity of an interoperability constituent, considered in isolation, to the technical specifications to be met,

• or the assessment/judgement by a notified body or bodies of the suitability for use of an interoperability constituent, considered within its railway environment and, in particular in cases where the interfaces are involved, in relation to the technical specifications, particularly those of a functional nature, which are to be checked.

The assessment procedures implemented by the notified bodies at the design and production stages will draw upon the modules defined in Decision 93/465/EEC, in accordance with the conditions referred to in the TSIs.

The ‘EC’ declaration of conformity or of suitability for use and the accompanying documents must be dated and signed.

That declaration must be written in the same language as the instructions and must contain the following:

• the Directive references,

• name and address of the manufacturer or its authorised representative established within the Community (give trade name and full address; in the case of the authorised representative, also give the trade name of the manufacturer),

• description of interoperability constituent (make, type, etc.),

• description of the procedure followed in order to declare conformity or suitability for use (Article 13),

• all the relevant descriptions met by the interoperability constituent and, in particular, its conditions of use,

• name and address of the notified body or bodies involved in the procedure followed in respect of conformity or suitability for use and date of examination certificate together with, where appropriate, the duration and conditions of validity of the certificate,

• where appropriate, reference to the European specifications,

• identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of the manufacturer's authorised representative established within the Community.

‘EC’ verification is the procedure whereby a notified body checks and certifies that the subsystem:

• complies with the Directive,

• complies with the other regulations deriving from the Treaty, and may be put into operation.

The subsystem is checked at each of the following stages:

• overall design,

• production: construction of subsystem, including, in particular, civil-engineering activities, manufacturing, constituent assembly, overall adjustment,

• final testing of the subsystem.

For the design stage (including the type tests) and for the production stage the applicant may apply for an assessment as a first step.

In this case, this assessment or assessments lead to one or more intermediate statement verifications (ISV) issued by the notified body chosen by the applicant. The notified body in turn draws up an ‘EC’ declaration of intermediate subsystem conformity for the relevant stages.

The notified body responsible for ‘EC’ verification assesses the design and production of the subsystem and draws up the certificate of verification intended for the applicant, which in turn draws up the ‘EC’ declaration of verification intended for the supervisory authority in the Member State in which the subsystem is located and/or operates.

If available, the notified body takes into account the ISVs, and, in order to issue the ‘EC’ certificate of verification, it:

• checks that the subsystem:

  • is covered by relevant design and production ISVs, if the applicant has asked the notified body for these two phases, or

  • corresponds as produced to all aspects covered by the design ISV delivered to the applicant, if it has asked the notified body only for the design phase,

• verifies that they cover correctly the requirement of the TSI and assesses the design and production elements that are not covered by the design and/or production ISV(s).

The technical file accompanying the declaration of verification must be made up as follows:

• for infrastructure: engineering-structure plans, approval records for excavations and reinforcement, testing and inspection reports on concrete, etc.,

• for the other subsystems: general and detailed drawings in line with execution, electrical and hydraulic diagrams, control-circuit diagrams, description of data-processing and automatic systems, operating and maintenance manuals, etc.,

• list of interoperability constituents, as referred to in Article 3, incorporated into the subsystem,

• copies of the ‘EC’ declarations of conformity or suitability for use with which the abovementioned constituents must be provided in accordance with Article 13 of the Directive accompanied, where appropriate, by the corresponding calculation notes and a copy of the records of the tests and examinations carried out by the notified bodies on the basis of the common technical specifications,

• if available, the ISV and, in such a case, the ‘EC’ declaration(s) of intermediate subsystem conformity, that accompany the ‘EC’ certificate of verification, including the result of verification by the notified body of their validity,

• certificate from the notified body responsible for ‘EC’ verification, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with this Directive and mentioning any reservations recorded during performance of the activities and not withdrawn; the certificate should also be accompanied by the inspection and audit reports drawn up by the same body in connection with its task, as specified in sections 5.3 and 5.4.

The complete file referred to in paragraph 4 must be lodged with the applicant in support of the ISV, if available, issued by the notified body responsible for this or in support of the certificate of conformity issued by the notified body responsible for verification of the subsystem in working order. The file must be attached to the ISV and/or to the ‘EC’ declaration of verification which the applicant sends to the supervisory authority in the Member State concerned.

A copy of the file must be kept by the applicant throughout the service life of the subsystem. It must be sent to any other Member States which so request.

Each notified body must periodically publish relevant information concerning:

• requests for ‘EC’ verification received,

• ISVs issued or refused,

• certificates of verification issued or refused,

• certificates of conformity refused.

The files and correspondence relating to the ‘EC’ verification procedures must be written in an official language of the Member State in which the applicant is established or in a language accepted by the applicant.

1. 1.1.

   General documentation

   General documentation (including description of new, renewed or upgraded vehicle and its intended use, design, repair, operation and maintenance information, technical file, etc.)

2. 1.2.

   Structure and mechanical parts

   Mechanical integrity and interface between vehicles (including draw and buffer gear, gangways), strength of vehicle structure and fittings (e.g. seats), loading capability, passive safety (including interior and exterior crashworthiness)

3. 1.3.

   Track interaction and gauging

   Mechanical interfaces to the infrastructure (including static and dynamic behaviour, clearances and fits, gauge, running gear, etc.)

4. 1.4.

   Braking equipment

   Braking-related items (including wheel-slide protection, braking control, and braking performance in service, emergency and parking modes)

5. 1.5.

   Passenger-related items

   Passenger facilities and passenger environment (including passenger windows and doors, requirements for persons with reduced mobility, etc.)

6. 1.6.

   Environmental conditions and aerodynamic effects

   Impact of the environment on the vehicle and impact of the vehicle on the environment (including aerodynamic conditions and both the interface between the vehicle and the trackside part of the railway system and the interface with the external environment)

7. 1.7.

   External warning, marking, functions and software integrity requirements

   External warnings, markings, functions and integrity of software, e.g. safety-related functions with an impact on train behaviour including train bus

8. 1.8.

   Onboard power supply and control systems

   Onboard propulsion, power and control systems, plus the interface of the vehicle with the power supply infrastructure and all aspects of electromagnetic compatibility

9. 1.9.

   Staff facilities, interfaces and environment

   Onboard facilities, interfaces, working conditions and environment for staff (including drivers cabs, driver machine interface)

10. 1.10.

    Fire safety and evacuation

11. 1.11.

    Servicing

    Onboard facilities and interfaces for servicing

12. 1.12.

    Onboard control, command and signalling

    All the onboard equipment necessary to ensure safety and to command and control movements of trains authorised to travel on the network and its effects on the trackside part of the railway system

13. 1.13.

    Specific operational requirements

    Specific operational requirements for vehicles (including degraded mode, vehicle recovery etc.)

14. 1.14.

    Freight related items

    Freight-specific requirements and environment (including facilities specifically required for dangerous goods)

Explanations and examples in italics above are for information only and are not definitions of the parameters.

The body, its Director and the staff responsible for carrying out the checking operations may not become involved either directly or as authorised representatives in the design, manufacture, construction, marketing or maintenance of the interoperability constituents or subsystems or in their use. This does not exclude the possibility of an exchange of technical information between the manufacturer and that body.

In particular, the body and the staff responsible for the checks must be functionally independent of the authorities designated to issue authorisations for placing in service in the framework of this Directive, licences in the framework of Directive 95/18/EC and safety certificates in the framework of Directive 2004/49/EC, and of the bodies in charge of investigations in the event of accidents.

The body must employ staff and possess the means required to perform adequately the technical and administrative tasks linked with the checks; it should also have access to the equipment needed for exceptional checks.

• proper technical and vocational training,

• a satisfactory knowledge of the requirements relating to the checks that they carry out and sufficient practice in those checks,

• the ability to draw up the certificates, records and reports which constitute the formal record of the inspections conducted.

The independence of the staff responsible for inspections must be guaranteed. No official must be remunerated either on the basis of the number of inspections performed or of the results of those inspections.

The body must take out civil liability insurance unless that liability is covered by the State under national law or unless the checks are carried out directly by that Member State.

The staff of the body are bound by professional secrecy with regard to everything they learn in the performance of their duties (with the exception of the competent administrative authorities and accident investigation bodies in the State where they perform those activities as well as accident investigation bodies responsible for the investigation of accidents caused by the failure of the interoperability constituents or subsystems checked) in pursuance of this Directive or any provision of national law implementing the Directive.