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anx_V__cpt_1__cpt_7__item_2__text_1

The manufacturer shall inform the notified body that holds the technical documentation relating to the EU type-examination certificate of all modifications to the approved type and of all modifications of the technical documentation that may affect the conformity of the PPE with the applicable essential health and safety requirements or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-01 · Text as adopted (Official Journal); later amendments are not incorporated in this text.