d1e1976-1-1__para__3
Where a modified product (38) is considered as a new product, it must comply with the provisions of the applicable legislation when it is made available or put into service. This has to be verified by applying the appropriate conformity assessment procedure laid down by the legislation in question. In particular, if the risk assessment leads to the conclusion that the modified product has to be considered as a new product, then the compliance of the modified product with the applicable essential requirements has to be reassessed and the person carrying out the substantial modification has to fulfil the same requirements as an original manufacturer, for example preparation of the technical documentation, drawing up a EU declaration of conformity and affixing the CE marking on the product.
Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.