Regulation 2(2)
1. EC verification is the procedure whereby a notified body checks and certifies, at the request of a contracting entity or of its authorised representative established within the Community, that a subsystem:
complies with the High-Speed Directive or the Conventional Directive;
complies with the other regulations deriving from the Treaty, and
may be put into operation.
2. The subsystem is checked at each of the following stages:
overall design;
construction of subsystem, including, in particular, civil-engineering activities, constituent assembly, overall adjustment;
final testing of the subsystem.
3. The notified body responsible for EC verification draws up the certificate of conformity intended for the contracting entity or its authorised representative established within the Community, 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.
4. 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;
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 of the High-Speed Directive or Article 3 of the Conventional Directive, 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 High-Speed Directive or Article 13 of the Conventional Directive and 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;
the certificate from the notified body responsible for EC verification, accompanied by corresponding calculation notes and countersigned by itself, stating that the project complies with the applicable Directive, and mentioning any reservations recorded during performance of the activities and not withdrawn; the certificate should also be accompanied by the inspection and audit reports drawn up by the same body in connection with its task, as specified in sections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.
5.1 The aim of EC monitoring is to ensure that the obligations deriving from the technical file have been met during production of the subsystem.
5.2 The notified body responsible for checking production must have permanent access to building sites, production workshops, storage areas and, where appropriate, prefabrication or testing facilities and, more generally, to all premises which it considers necessary for its task. The contracting entity or its authorised representative within the Community must send it or have sent to it all the documents needed for that purpose and, in particular, the implementation plans and technical documentation concerning the subsystem.
5.3 The notified body responsible for checking implementation must periodically carry out audits in order to confirm compliance with the High-Speed Directive or Conventional Directive. It must provide those responsible for implementation with an audit report. It may require to be present at certain stages of the building operations.
5.4 In addition, the notified body may pay unexpected visits to the worksite or to the production workshops. At the time of such visits the notified body may conduct complete or partial audits. It must provide those responsible for implementation with an inspection report and, if appropriate, an audit report.
6. The complete file referred to in paragraph 4 must be lodged with the contracting entity or its authorised agent established within the Community 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 EC declaration of verification which the contracting entity sends to the Safety Authority.
A copy of the file must be kept by the contracting entity throughout the service life of the subsystem. The file must be sent to any other Member State that requests a copy.
7. Each notified body must periodically publish relevant information concerning:
requests for EC verification received;
certificates of conformity issued;
certificates of conformity refused.
8. The files and correspondence relating to the EC verification procedures must be written in English or in a language accepted by the contracting entity.