Definition

Product with digital elements

Also: PDE

Any software or hardware product and its remote data processing solutions, including components placed on the market separately.

A software or hardware product and its remote data processing solutions, including software or hardware components placed on the market separately. The definition is deliberately broad: apps, firmware, operating systems, connected devices, libraries sold commercially and the cloud back-end a device depends on to function are all covered. Products already regulated by sector rules (medical devices, aviation, vehicles, marine equipment) and products developed exclusively for national security or defence are excluded.

Reference: Art. 3(1); exclusions in Art. 2 · Regulation (EU) 2024/2847 on EUR-Lex

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