Recital 111 Restricting or forbidding the free movement of a product with digital elements


In certain cases, 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; which complies with this Regulation can nonetheless present 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; or pose a 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; to the health or safety of persons, to compliance with obligations under Union or national law intended to protect fundamental rights, 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 or to other aspects of public interest protection. Therefore it is necessary to establish rules which ensure mitigation of those 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;. As a result, market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; should take measures to require the economic operator means the manufacturer, the authorised representative, the importer, the distributor, or other natural or legal person who is subject to obligations in relation to the manufacture of products with digital elements or to the making available of products with digital elements on the market in accordance with this Regulation; to ensure that the product no longer presents that 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;, or to recall means recall as defined in Article 3, point (22), of Regulation (EU) 2019/1020; or withdraw it, depending on 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;. As soon as a market surveillance authority means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; restricts or forbids the free movement 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; in such way, the Member State should notify without delay the Commission and the other Member States of the provisional measures, indicating the reasons and justification for the decision. Where a market surveillance authority means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; adopts such measures against 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 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 enter into consultation with the Member States and the relevant economic operator means the manufacturer, the authorised representative, the importer, the distributor, or other natural or legal person who is subject to obligations in relation to the manufacture of products with digital elements or to the making available of products with digital elements on the market in accordance with this Regulation; or operators without delay and should evaluate the national measure. On the basis of the results of this evaluation, the Commission should decide whether the national measure is justified or not. The Commission should address its decision to all Member States and immediately communicate it to them and the relevant economic operator means the manufacturer, the authorised representative, the importer, the distributor, or other natural or legal person who is subject to obligations in relation to the manufacture of products with digital elements or to the making available of products with digital elements on the market in accordance with this Regulation; or operators. If the measure is considered to be justified, the Commission should also consider whether to adopt proposals to revise the relevant Union law.

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