Article 16 - Other cases in which obligations of manufacturers apply
A natural or legal person, other than the manufacturer, the importer or the distributor, that carries out a substantial modification of the product with digital elements shall be considered a manufacturer for the purposes of this Regulation.
That person shall be subject to the obligations of the manufacturer set out in Articles 10 and 11(1), (2), (4) and (7), for the part of the product that is affected by the substantial modification or, if the substantial modification has an impact on the cybersecurity of the product with digital elements as a whole, for the entire product.
Cyber Resilience Act Text 15.9.2022
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Digital Operational Resilience Act (DORA)