Article 46 - Compliant products with digital elements which present a significant cybersecurity risk
1. Where, having performed an evaluation under Article 43, the market surveillance authority of a Member State finds that although a product with digital elements and the processes put in place by the manufacturer are in compliance with this Regulation, they present a significant cybersecurity risk and, in addition, they pose a risk to the health or safety of persons, to the compliance with obligations under Union or national law intended to protect fundamental rights, the availability authenticity, integrity or confidentiality of services offered using an electronic information system by essential entities of the type referred to in [Annex I to Directive XXX / XXXX (NIS2)] or to other aspects of public interest protection, it shall require the relevant operator to take all appropriate measures to ensure that the product with digital elements and the processes put in place by the manufacturer concerned, when placed on the market, no longer present that risk, to withdraw the product with digital elements from the market or to recall it within a reasonable period, commensurate with the nature of the risk.
2. The manufacturer or other relevant operators shall ensure that corrective action is taken in respect of the products with digital elements concerned that they have made available on the market throughout the Union within the timeline established by the market surveillance authority of the Member State referred to in paragraph 1.
3. The Member State shall immediately inform the Commission and the other Member States about the measures taken pursuant to paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the products with digital elements concerned, the origin and the supply chain of those products with digital elements, the nature of the risk involved and the nature and duration of the national measures taken.
4. The Commission shall without delay enter into consultation with the Member States and the relevant economic operator and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether the measure is justified or not and, where necessary, propose appropriate measures.
5. The Commission shall address its decision to the Member States.
6. Where the Commission has sufficient reasons to consider, including based on information provided by ENISA, that a product with digital elements, although compliant with this Regulation, presents the risks referred to in paragraph 1, it may request the relevant market surveillance authority or authorities to carry out an evaluation of compliance and follow the procedures referred to in Article 43 and paragraphs 1, 2 and 3 of this Article.
7. In exceptional circumstances which justify an immediate intervention to preserve the good functioning of the internal market and where the Commission has sufficient reasons to consider that the product referred to in paragraph 6 continues to present the risks referred to in paragraph 1 and no effective measures have been taken by the relevant national market surveillance authorities, the Commission may request ENISA to carry out an evaluation of the risks presented by that product and shall inform the relevant market surveillance authorities accordingly. The relevant economic operators shall cooperate as necessary with ENISA.
8. Based on ENISA’s evaluation referred to in paragraph 7, the Commission may establish that a corrective or restrictive measure is necessary at Union level. To this end, it shall without delay consult the Member States concerned and the relevant operator or operators.
9. On the basis of the consultation referred to in paragraph 8, the Commission may adopt implementing acts to decide on corrective or restrictive measures at Union level, including ordering withdrawal from the market, or recalling, within a reasonable period, commensurate with the nature of the risk. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 51(2).
10. The Commission shall immediately communicate the decision referred to in the paragraph 9 to the relevant operator or operators. Member States shall implement such acts without delay and shall inform the Commission accordingly.
11. Paragraphs 6 to 10 shall apply for the duration of the exceptional situation that justified the Commission’s intervention and for as long as the respective product continues to present the risks referred to in paragraph 1.
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