CHAPTER III

Member States shall take all necessary steps to ensure that interoperability constituents: are placed on the market only if they enable interoperability to be achieved within the rail system while at the same time meeting the essential requirements; are used in their area of use as intended and are suitably installed and maintained. These provisions shall not obstruct the placing on the market of these constituents for other applications. Member States may not, in their territory and on the basis of this Directive, prohibit, restrict or hinder the placing on the market of interoperability constituents for use in the rail system where they comply with this Directive. In particular, they may not require checks which have already been carried out as part of the procedure of ‘EC’ declaration of conformity or suitability for use, the components of which are set out in Annex IV. Member States shall consider those interoperability constituents which bear the ‘EC’ declaration of conformity or suitability for use as complying with the essential requirements of this Directive. All interoperability constituents shall be subject to the procedure for assessing conformity and suitability for the use indicated in the relevant TSI and shall be accompanied by the corresponding certificate. Member States shall consider that an interoperability constituent meets the essential requirements if it complies with the conditions laid down by the corresponding TSI or the corresponding European specifications developed to comply with these conditions. Spare parts for subsystems that are already placed in service when the corresponding TSI enters into force may be installed in these subsystems without being subject to the procedure referred to in paragraph 2. TSIs may provide for a period of transition for rail products identified by those TSIs as interoperability constituents which have already been placed on the market when the TSIs enter into force. Such constituents shall satisfy the requirements of Article 10(1). Where it appears to a Member State or the Commission that European specifications used directly or indirectly to achieve the objectives of this Directive do not meet the essential requirements, the committee referred to in Article 29 shall be informed thereof and the Commission shall adopt the most appropriate measure, being: partial or total withdrawal of the specifications concerned from the publications containing them, or their amendment, after consultation, where European standards are involved, of the Committee set up under Directive 98/34/EC, or review of the TSI in accordance with Article 7. In order to establish the ‘EC’ declaration of conformity or suitability for use of an interoperability constituent, the manufacturer or his authorised representative established in the Community shall apply the provisions laid down by the relevant TSIs. Where the corresponding TSI so requires, assessment of the conformity or suitability for use of an interoperability constituent shall be carried out by the notified body with which the manufacturer or his authorised representative established in the Community has lodged the application. Where interoperability constituents are the subject of other Community directives covering other aspects, the ‘EC’ declaration of conformity or suitability for use shall, in such cases, state that the interoperability constituents also meet the requirements of those other directives. Where neither the manufacturer nor his authorised representative established in the Community has met the obligations of paragraphs 1 and 3, those obligations shall be incumbent on any person who places interoperability constituents on the market. The same obligations shall apply to whomsoever assembles interoperability constituents or parts of interoperability constituents having diverse origins or manufactures interoperability constituents for his own use, for the purposes of this Directive. Without prejudice to the provisions of Article 14: in each instance where the Member State finds that the ‘EC’ declaration of conformity has been drawn up improperly, the manufacturer or his authorised representative established in the Community shall be required, if necessary, to restore the interoperability constituent to a state of conformity and to terminate the infringement under the conditions laid down by that Member State; where non-conformity persists, the Member State shall take all appropriate steps to restrict or prohibit the placing on the market of the interoperability constituent in question, or to ensure that it is withdrawn from the market in accordance with the procedures provided for in Article 14. Where a Member State finds that an interoperability constituent covered by the ‘EC’ declaration of conformity or suitability for use and placed on the market is unlikely, when used as intended, to meet the essential requirements, it shall take all necessary steps to restrict its field of application, prohibit its use or withdraw it from the market. The Member State shall forthwith inform the Commission of the measures taken and give the reasons for its decision, stating in particular whether failure to conform is due to: failure to meet the essential requirements; incorrect application of European specifications where application of such specifications is relied upon; inadequacy of European specifications. The Commission shall consult the parties concerned as quickly as possible. Where, following that consultation, the Commission establishes that the measure is justified it shall forthwith inform the Member State that has taken the initiative as well as the other Member States thereof. Where, after that consultation, the Commission establishes that the measure is unjustified it shall forthwith inform the Member State that has taken the initiative and the manufacturer or his authorised representative established within the Community thereof. Where the decision referred to in paragraph 1 is justified by the existence of a gap in European specifications, the procedure set out in Article 12 shall apply. Where an interoperability constituent bearing the ‘EC’ declaration of conformity fails to comply, the competent Member State shall take appropriate measures against whomsoever has drawn up the declaration and shall inform the Commission and the other Member States thereof. The Commission shall ensure that the Member States are kept informed of the course and results of that procedure.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.