2.
Manufacturers shall draw up the technical documentation referred to in Annex III (‘technical documentation’) and carry out the applicable conformity assessment procedure referred to in Article 19 or have it carried out. Where compliance of PPE with the applicable essential health and safety requirements has been demonstrated by the appropriate procedure, manufacturers shall draw up the EU declaration of conformity referred to in Article 15 and affix the CE marking referred to in Article 16.
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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.