Product with digital elements
Everything hinges on this term: only those who place a product with digital elements on the market fall under the CRA. The definition is broad and covers more than many manufacturers expect.
A product with digital elements, under the CRA, is any software or hardware product, together with its data processing solutions, whose intended use includes a direct or indirect data connection to a device or network. This also covers components placed on the market separately.
Definition in the Regulation
Article 3, point (1) defines the term as "a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately". Article 2(1) adds the condition: the Regulation applies to such products where their use includes a direct or indirect logical or physical data connection. Under Article 3, point (2), remote data processing forms part of the product if the manufacturer designed and developed the software itself or under its responsibility, and the product could not perform one of its functions without it.
According to recital 12, pure online services such as SaaS with no product on the user's side are not covered; they may fall under NIS2. Also excluded are the sectoral areas in Article 2(2) to (7) and free and open-source software that is not made available in the course of a commercial activity.
What it means for manufacturers
A machine controller with an Ethernet port, a sensor with Bluetooth, a desktop application, an app, firmware, a software library, a microcontroller: all of these are products with digital elements as soon as they are made available in the EU in the course of a commercial activity. The cloud back end of a machine run by the manufacturer also forms part of the product if remote monitoring or remote control fails without it. For each of these products, the reporting obligation under Article 14 has applied since 11 September 2026, and the full set of obligations applies from 11 December 2027. Whether a specific product is covered can be determined in a few minutes with the Applicability Check.
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- Remote data processing
- Placing on the market
- Commercial activity
- Sectoral exclusions
- Free and open-source software