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 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 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. 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, or to recall means recall as defined in Article 3, point (22), of Regulation (EU) 2019/1020; or withdraw it, depending on the risk. 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, 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.