Cyber Resilience Act, Preamble 101 to 110 (Final Text)
(101) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, should be considered by the national public authorities throughout the Union to be the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.
(102) Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for a product with digital elements to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks.
(103) The notification of a conformity assessment body should be sent by the notifying authority to the Commission and the other Member States via the New Approach Notified and Designated Organisations (NANDO) information system. The NANDO information system is the electronic notification tool developed and managed by the Commission where a list of all notified bodies can be found.
(104) Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.
(105) In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burden for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That should be best achieved through appropriate coordination and cooperation between notified bodies.
(106) Market surveillance is an essential instrument in ensuring the proper and uniform application of Union law. It is therefore appropriate to put in place a legal framework within which market surveillance can be carried out in an appropriate manner. The rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EU) 2019/1020 apply to products with digital elements that fall within the scope of this Regulation.
(107) In accordance with Regulation (EU) 2019/1020, a market surveillance authority carries out market surveillance in the territory of the Member State that designates it. This Regulation should not prevent Member States from choosing the competent authorities to carry out market surveillance tasks. Each Member State should designate one or more market surveillance authorities in its territory. Member States should be able to choose to designate any existing or new authority to act as market surveillance authority, including competent authorities designated or established pursuant to Article 8 of Directive (EU) 2022/2555, national cybersecurity certification authorities designated pursuant to Article 58 of Regulation (EU) 2019/881 or market surveillance authorities designated for the purposes of Directive 2014/53/EU.
Economic operators should fully cooperate with market surveillance authorities and other competent authorities. Each Member State should inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities and should ensure the necessary resources and skills to carry out the market surveillance tasks relating to this Regulation. Pursuant to Article 10(2) and (3) of Regulation (EU) 2019/1020, each Member State should appoint a single liaison office that should be responsible, inter alia, for representing the coordinated position of the market surveillance authorities and assisting in the cooperation between market surveillance authorities in different Member States.
(108) A dedicated ADCO for the cyber resilience of products with digital elements should be established for the uniform application of this Regulation, pursuant to Article 30(2) of Regulation (EU) 2019/1020. ADCO should be composed of representatives of the designated market surveillance authorities and, if appropriate, representatives of the single liaison offices.
The Commission should support and encourage cooperation between market surveillance authorities through the Union Product Compliance Network established pursuant to Article 29 of Regulation (EU) 2019/1020 and comprising representatives from each Member State, including a representative of each single liaison office as referred to in Article 10 of that Regulation and an optional national expert, the chairs of ADCOs, and representatives from the Commission.
The Commission should participate in the meetings of the Union Product Compliance Network, its sub-groups and ADCO. It should also assist ADCO by means of an executive secretariat that provides technical and logistic support. ADCO may also invite independent experts to participate, and liaise with other ADCOs, such as that established under Directive 2014/53/EU.
(109) Market surveillance authorities, through ADCO established under this Regulation, should cooperate closely and should be able to develop guidance documents to facilitate market surveillance activities at national level, such as by developing best practices and indicators to effectively check the compliance of products with digital elements with this Regulation.
(110) In order to ensure timely, proportionate and effective measures in relation to products with digital elements presenting a significant cybersecurity risk, a Union safeguard procedure under which interested parties are informed of measures intended to be taken with regard to such products should be provided for. This should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage where necessary. Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard.
Cyber Resilience Act Final Text
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