Data & Privacy
AI & Trust
Cybersecurity
Digital Services & Media
CHAPTER I
GENERAL PROVISIONSArticles 1 — 12
CHAPTER II
OBLIGATIONS OF ECONOMIC OPERATORS AND PROVISIONS IN RELATION TO FREE AND OPEN-SOURCE SOFTWAREArticles 13 — 26
CHAPTER III
CONFORMITY OF THE PRODUCT WITH DIGITAL ELEMENTSArticles 27 — 34
CHAPTER IV
NOTIFICATION OF CONFORMITY ASSESSMENT BODIESArticles 35 — 51
CHAPTER V
MARKET SURVEILLANCE AND ENFORCEMENTArticles 52 — 60
CHAPTER VI
DELEGATED POWERS AND COMMITTEE PROCEDUREArticles 61 — 62
CHAPTER VII
CONFIDENTIALITY AND PENALTIESArticles 63 — 65
CHAPTER VIII
TRANSITIONAL AND FINAL PROVISIONSArticles 66 — 71
ANNEXES
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.
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.
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.
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.