sec_4_3__para
Union harmonisation legislation obliges the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements. This documentation may be part of the quality system documentation where the legislation provides for a conformity assessment procedure based on a quality system (modules D, E, H and their variants). The technical documentation must be available when the product is placed on the market, whatever its geographical origin or location (218).
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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.