Source: OJ L 2024/2847, 20.11.2024
ENRecital 112 Commission's power in exceptional circumstances
For 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; presenting a significant cybersecurity risk means a cybersecurity risk which, based on its technical characteristics, can be assumed to have a high likelihood of an incident that could lead to a severe negative impact, including by causing considerable material or non-material loss or disruption;, and where there is reason to believe that they do not comply with this Regulation, or for products that comply with this Regulation, but that present other important 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;, such as 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; to the health or safety of persons, to compliance with obligations under Union or national law intended to protect fundamental rights or to the availability, authenticity, integrity or confidentiality of services offered using an electronic information system means a system, including electrical or electronic equipment, capable of processing, storing or transmitting digital data; by essential entities means a natural or legal person created and recognised as such under the national law of its place of establishment, which may, acting under its own name, exercise rights and be subject to obligations; as referred to in Article 3(1) of Directive (EU) 2022/2555, the Commission should be able to request ENISA to carry out an evaluation. Based on that evaluation, the Commission should be able to adopt, by means of implementing acts, corrective or restrictive measures at Union level, including requiring the 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processing solutions, including software or hardware components being placed on the market separately; concerned to be withdrawn from the market or recalled, within a reasonable period, commensurate with the nature of the risk means the potential for loss or disruption caused by an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;. The Commission should be able to have recourse to such intervention only in exceptional circumstances that justify an immediate intervention to preserve the proper functioning of the internal market, and only where no effective measures have been taken by market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; to remedy the situation. Such exceptional circumstances may be emergency situations where, for example, a non-compliant 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 widely made available 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; throughout several Member States, used also in key sectors by entities means a natural or legal person created and recognised as such under the national law of its place of establishment, which may, acting under its own name, exercise rights and be subject to obligations; that fall within the scope of Directive (EU) 2022/2555 while containing known vulnerabilities means a weakness, susceptibility or flaw of a product with digital elements that can be exploited by a cyber threat; that are being exploited by malicious actors and for which 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; does not provide available patches. The Commission should be able to intervene in such emergency situations only for the duration of the exceptional circumstances and if non-compliance with this Regulation or the important 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; presented persist.