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
Simultaneous coordinated control actions (sweeps) are specific enforcement actions by market surveillance authorities that can further enhance product security. Sweeps should, in particular, be conducted where market trends, consumer complaints or other indications suggest that certain categories of products with digital elements are often found to present cybersecurity risks. Furthermore, when determining the product categories to be subjected to sweeps, market surveillance authorities should also take into account circumstances relating to non-technical risk factors. To that end, market surveillance authorities should be able to take into account the results of Union level coordinated security risk assessments of critical supply chains carried out in accordance with Article 22 of Directive (EU) 2022/2555, including circumstances relating to non-technical risk factors. ENISA should submit proposals for categories of products with digital elements for which sweeps could be organised to the market surveillance authorities, based, inter alia, on the notifications of vulnerabilities and incidents it receives.
In light of its expertise and mandate, ENISA should be able to support the process for implementation of this Regulation. In particular, ENISA should be able to propose joint activities to be conducted by market surveillance authorities based on indications or information regarding potential non-compliance with this Regulation of products with digital elements across several Member States or identify categories of products for which sweeps should be organised. In exceptional circumstances, ENISA should be able, at the request of the Commission, to conduct evaluations in respect of specific products with digital elements that present a significant cybersecurity risk, where an immediate intervention is required to preserve the proper functioning of the internal market.
This Regulation confers certain tasks upon ENISA which require appropriate resources in terms of both expertise and human resources in order to enable ENISA to carry out those tasks effectively. The Commission will propose the necessary budgetary resources for ENISA’s establishment plan, in accordance with the procedure set out in Article 29 of Regulation (EU) 2019/881, when preparing the draft general budget of the Union. During that process, the Commission will consider ENISA’s overall resources to enable it to fulfil its tasks, including those conferred on ENISA pursuant to this Regulation.