4. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured apparatus with the technical documentation referred to in point 3 of this Annex and with the essential requirements set out in point 1 of Annex I.
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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.