(16)
‘substantial modification’ means a modification of machinery or a related product, by physical or digital means after that machinery or related product has been placed on the market or put into service, which is not foreseen or planned by the manufacturer, and which affects the safety of that machinery or related product, by creating a new hazard, or by increasing an existing risk, which requires: the addition of guards or protective devices to that machinery or related product the processing of which necessitates the modification of the existing safety control system; or the adoption of additional protective measures to ensure the stability or mechanical strength of that machinery or related product;
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Source: EUR-Lex CELLAR · retrieved 2026-08-26 · Text as adopted (Official Journal); later amendments are not incorporated in this text.