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5. CE marking and EU declaration of conformity

The manufacturer shall affix the CE marking to each individual apparatus that satisfies the applicable requirements of this Directive. The manufacturer shall draw up a written EU declaration of conformity for an apparatus model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the apparatus has been placed on the market. The EU declaration of conformity shall identify the apparatus for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

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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.