Recital 42 Substantial modification via refurbishment, maintenance and repair

Where a product 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; is subject to ‘refurbishment’, ‘maintenance’ and ‘repair’ as defined in Article 2, points (18), (19) and (20), of Regulation (EU) 2024/1781 of the European Parliament and of the Council(¹⁹)Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L, 2024/1781, 28.6.2024, ELI: http://data.europa.eu/eli/reg/2024/1781/oj)., this does not necessarily lead to a substantial modification means 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; of the product, for instance if the intended purpose means the use for which a product with digital elements is intended by the manufacturer, including the specific context and conditions of use, as specified in the information supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation; and functionalities are not changed and the level of risk 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; remains unaffected. However, an upgrade of a product 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; by the manufacturer means a natural or legal person who develops or manufactures products with digital elements or has products with digital elements designed, developed or manufactured, and markets them under its name or trademark, whether for payment, monetisation or free of charge; might lead to changes in the design and development of that product and might therefore affect its intended purpose means the use for which a product with digital elements is intended by the manufacturer, including the specific context and conditions of use, as specified in the information supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation; and compliance with the requirements set out in this Regulation.