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If the demonstration of conformity of products against an approved EU-type cannot be left to the manufacturer but requires that products are supervised by a notified body during the production process, then the legislator may require from the manufacturer either to operate an approved quality system (modules D, E) or that the conformity of his products are verified be means of tests/checks (module F). In this respect, if the production mechanism is relatively ‘simple’ then the legislator may consider that it sufficient that the quality system of the manufacturer focuses only on the test of the final product without including the pure manufacturing part. If this is the case, module E is the most appropriate.

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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.