sec_7_4_2_2__para__2
The corrective action depends on the risk or non-compliance and, thus, must be in accordance with the principle of proportionality. Non-conformity to essential requirements must generally be considered as a substantial non-compliance, because this may lead to the product presenting a potential or actual risk to the health and safety of persons or to other aspects of public interest.
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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.