A change to the product with digital elements following its placing on the market, which affects the compliance of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I or which results in a modification to the intended purpose for which the product with digital elements has been assessed
Defined in / by
Also defined different in / by
- Substantial modification defined in / by EU AI Act (32024R1689)
Last updated: 22 August 2026.