Article 18

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. 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. 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. 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. If the relevant TSIs allow, the notified body may issue certificates of conformity for a series of subsystems or certain parts of those subsystems.

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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.