1.Without prejudice to Chapter V, each Member State shall authorise the placing in service of those structural subsystems constituting the rail system which are located or operated in its territory.
To this end, Member States shall take all appropriate steps to ensure that these subsystems may be placed in service only if they are designed, constructed and installed in such a way as to meet the essential requirements concerning them when integrated into the rail system. In particular, they shall check:
the technical compatibility of these subsystems with the system into which they are being integrated,
the safe integration of these subsystems in accordance with Articles 4(3) and 6(3) of Directive 2004/49/EC.
2.Each Member State shall check, before these subsystems are placed in service, that they comply, where applicable, with the relevant TSI provisions on operation and maintenance.
3.After these subsystems have been placed in service, the check shall be carried out:
(a)for infrastructures, in the context of the granting and supervision of safety authorisations under Article 11 of Directive 2004/49/EC;
(b)for vehicles, in the context of the granting and supervision of safety certificates under Article 10 of Directive 2004/49/EC.
To that end, the assessment and verification procedures laid down in the relevant structural and functional TSIs shall be used.
Without prejudice to the provisions of Article 15(1), Member States may not, in their territory and on grounds relating to this Directive, prohibit, restrict or hinder the construction, placing in service and operation of structural subsystems constituting the rail system which meet the essential requirements. In particular, they may not require checks which have already been carried out:
either as part of the procedure leading to the ‘EC’ declaration of verification, the components of which are set out in Annex V,
or in other Member States, before or after the entry into force of this Directive, with a view to verifying compliance with identical requirements under identical operational conditions.
1.Member States shall consider as being interoperable and meeting the essential requirements concerning them, those structural subsystems constituting the rail system which are covered by the ‘EC’ declaration of verification.
2.Verification of the interoperability, in accordance with the essential requirements, of a structural subsystem constituting the rail system shall be established by reference to TSIs, where they exist.
3.Member States shall draw up, for each subsystem, a list of the technical rules in use for implementing the essential requirements and notify this list to the Commission when:
no relevant TSI exists, or
a derogation has been notified under Article 9, or
a specific case requires the application of technical rules not included in the relevant TSI.
This list shall be notified either:
each time the list of technical rules that, pursuant to Article 16(3) of Directive 96/48/EC and Article 16(3) of Directive 2001/16/EC, was required to be notified by 30 April 2005 is changed, or
after the derogation has been notified, or
after publication of the TSI concerned.
On that occasion, Member States shall also designate the bodies responsible for carrying out, in the case of these technical regulations, the verification procedure referred to in Article 18.
The Commission shall communicate this information to the Agency, which shall publish it.
Member States shall make available the full text of the notified rules at the request of the Commission. In order to prevent further barriers from being created, and with a view to taking forward the classification of national rules in accordance with Article 27, the Commission shall monitor the introduction of new rules by the Member States. If the Commission considers that the new rule constitutes a means of arbitrary discrimination or a disguised restriction on rail transport operations between Member States, a decision, addressed to the Member State concerned, shall be adopted in accordance with the regulatory procedure referred to in Article 29(3).
Member States may choose not to notify rules and restrictions of a strictly local nature. In such cases, Member States shall mention such rules and restrictions in the infrastructure registers referred to in Article 35.
Member States shall ensure that binding technical rules are published and made available to all infrastructure managers, railway undertakings and applicants for authorisations for placing in service in clear language that can be understood by the parties concerned.
1.In order to establish the ‘EC’ declaration of verification, the applicant shall invite the notified body that it has selected for that purpose to apply the ‘EC’ verification procedure referred to in Annex VI. The applicant may be the contracting entity or the manufacturer, or their authorised representative within the Community.
2.The task of the notified body responsible for the ‘EC’ verification of a subsystem shall begin at the design stage and cover the entire manufacturing period through to the acceptance stage before the subsystem is placed in service. It shall also cover verification of the interfaces of the subsystem in question with the system into which it is incorporated, based on the information available in the relevant TSI and in the registers provided for in Articles 34 and 35.
3.The notified body shall be responsible for compiling the technical file that has to accompany the ‘EC’ declaration of verification. This 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 interoperability constituents. It should also contain all the elements relating to the conditions and limits of use and to the instructions concerning servicing, constant or routine monitoring, adjustment and maintenance.
4.The notified body may issue intermediate statement verifications to cover certain stages of the verification procedure or certain parts of the subsystem. In such a case, the procedure set out in Annex VI shall apply.
5.If the relevant TSIs allow, the notified body may issue certificates of conformity for a series of subsystems or certain parts of those subsystems.
1.Where a Member State finds that a structural subsystem covered by the ‘EC’ declaration of verification accompanied by the technical file does not fully comply with this Directive and in particular does not meet the essential requirements, it may request that additional checks be carried out.
2.The Member State making the request shall forthwith inform the Commission of any additional checks requested and set out the reasons therefor. The Commission shall consult the interested parties.
3.The Member State making the request shall state whether the failure to fully comply with this Directive is due to:
(a)non-compliance with the essential requirements or with a TSI, or incorrect application of a TSI. In that case, the Commission shall forthwith inform the Member State where the person who drew up the ‘EC’ declaration of verification in error resides and shall request that Member State to take the appropriate measures;
(b)inadequacy of a TSI. In that case, the procedure for amending the TSI as referred to in Article 7 shall apply.
1.In the event of renewal or upgrading, the contracting entity or the manufacturer shall send the Member State concerned a file describing the project. The Member State shall examine this file and, taking account of the implementation strategy indicated in the applicable TSI, shall decide whether the extent of the works means that a new authorisation for placing in service within the meaning of this Directive is needed.
Such new authorisation for placing in service shall be required whenever the overall safety level of the subsystem concerned may be adversely affected by the works envisaged. If a new authorisation is needed, the Member State shall decide to what extent the TSIs need to be applied to the project.
The Member State shall take its decision not later than four months after submission of the complete file by the applicant.
2.When a new authorisation is required and if the TSI is not fully applied, the Member States shall notify the following information to the Commission:
the reason why the TSI is not fully applied,
the technical characteristics applicable in place of the TSI,
the bodies responsible for applying, in the case of those characteristics, the verification procedure referred to in Article 18.
3.The Commission shall communicate the information referred to in paragraph 2 to the Agency, which shall publish it.