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Conformity assessment is performed with the involvement of an accredited in-house conformity assessment body that forms a part of the manufacturer’s organisation. However this in-house body must not have any activities other than conformity assessment and must be independent from any commercial, design and production entities (see for details Article R21 of Annex I of Decision No 768/2008/EC). It has to demonstrate the same technical competence and impartiality as external conformity assessment bodies, through accreditation.

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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.