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Version status: Published | Document consolidation status: No known changes
Version date: 20 November 2024 - onwards

Article 57 Compliant products with digital elements which present a significant cybersecurity risk

1. The market surveillance authority of a Member State shall require an economic operator to take all appropriate measures where, having performed an evaluation under Article 54, it finds that although aproduct with digital elements and the processes put in place by the manufacturer are in compliance with this Regulation, they present a significant cybersecurity risk as well as 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 measures to ensure that the product with digital elements concerned and the processes put in place by the manufacturer no longer present the relevant risks when made available on the market, withdrawal from the market of the product with digital elements concerned, or recalling of it, and shall be commensurate with the nature of those risks.