Article 11 General product safety

By way of derogation from Article 2(1), third subparagraph, point (b), of Regulation (EU) 2023/988, Chapter III, Section 1, Chapters V and VII, and Chapters IX to XI of that Regulation shall apply to products with digital elements means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately; with respect to aspects and risks means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident; or categories of risks means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident; that are not covered by this Regulation where those products are not subject to specific safety requirements laid down in other ‘Union harmonisation legislation means Union legislation listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for the marketing of products to which that Regulation applies;’ as defined in Article 3, point (27), of Regulation (EU) 2023/988.