lexiara

anx_SUBSYSTEMS__cpt_6__text_1

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.

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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.