Definition

Substantial modification

A change after placing on the market that affects compliance with the essential requirements or changes the intended purpose.

A change to the product with digital elements following its placing on the market which affects the compliance of the product with the essential cybersecurity requirements or which results in a modification of the intended purpose for which the product has been assessed. Security updates that reduce risk are expressly not substantial modifications; a new feature set that changes the risk profile can be. Manufacturers should document the assessment per release.

Reference: Art. 3 (definition of substantial modification); Art. 13 · Regulation (EU) 2024/2847 on EUR-Lex

Updated 2026-09-12 · Paraphrase for orientation, not legal advice.