Compliant products with digital elements which present a significant cybersecurity risk 構成重大網路安全風險之合規產品

1. The market surveillance authority of a Member State shall take appropriate measures where, having performed an evaluation under Article 54, it finds that although a product with digital elements and the processes put in place by the manufacturer comply with this Regulation, it presents a significant cybersecurity risk and, in addition, presents a risk to: (a) the health or safety of persons; (b) the compliance with obligations under Union or national law intended to protect fundamental rights; (c) the availability, authenticity, integrity or confidentiality of services offered using an electronic information system by essential entities as referred to in Article 3(1) of Directive (EU) 2022/2555; or (d) other aspects of public interest protection.

The measures referred to in the first subparagraph may include the requirement that the relevant economic operator takes all appropriate measures to ensure that, when placed on the market, that product with digital elements no longer presents that risk, withdrawing it from the market or recalling it within a reasonable period commensurate with the nature of the risk, as the market surveillance authority may prescribe.

2. The economic operator shall ensure that corrective action is taken in respect of all the products with digital elements concerned that it has made available on the market throughout the Union.

3. The market surveillance authority shall immediately inform the Commission and the other Member States of the measures taken in accordance with paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the product with digital elements concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.