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Table of Contents

CHAPTER I GENERAL PROVISIONS
⊞ ▼
  • Article 1 Subject matter
  • Article 2 Scope
  • Article 3 Definitions
  • Article 4 Free movement
  • Article 5 Procurement or use of products with digital elements
  • Article 6 Requirements for products with digital elements
  • Article 7 Important products with digital elements
  • Article 8 Critical products with digital elements
  • Article 9 Stakeholder consultation
  • Article 10 Enhancing skills in a cyber resilient digital environment
  • Article 11 General product safety
  • Article 12 High-risk AI systems
CHAPTER II OBLIGATIONS OF ECONOMIC OPERATORS AND PROVISIONS IN RELATION TO FREE AND OPEN-SOURCE SOFTWARE
⊞ ▼
  • Article 13 Obligations of manufacturers
  • Article 14 Reporting obligations of manufacturers
  • Article 15 Voluntary reporting
  • Article 16 Establishment of a single reporting platform
  • Article 17 Other provisions related to reporting
  • Article 18 Authorised representatives
  • Article 19 Obligations of importers
  • Article 20 Obligations of distributors
  • Article 21 Cases in which obligations of manufacturers apply to importers and distributors
  • Article 22 Other cases in which obligations of manufacturers apply
  • Article 23 Identification of economic operators
  • Article 24 Obligations of open-source software stewards
  • Article 25 Security attestation of free and open-source software
  • Article 26 Guidance
CHAPTER III CONFORMITY OF THE PRODUCT WITH DIGITAL ELEMENTS
⊞ ▼
  • Article 27 Presumption of conformity
  • Article 28 EU declaration of conformity
  • Article 29 General principles of the CE marking
  • Article 30 Rules and conditions for affixing the CE marking
  • Article 31 Technical documentation
  • Article 32 Conformity assessment procedures for products with digital elements
  • Article 33 Support measures for microenterprises and small and medium-sized enterprises, including start-ups
  • Article 34 Mutual recognition agreements
CHAPTER IV NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
⊞ ▼
  • Article 35 Notification
  • Article 36 Notifying authorities
  • Article 37 Requirements relating to notifying authorities
  • Article 38 Information obligation on notifying authorities
  • Article 39 Requirements relating to notified bodies
  • Article 40 Presumption of conformity of notified bodies
  • Article 41 Subsidiaries of and subcontracting by notified bodies
  • Article 42 Application for notification
  • Article 43 Notification procedure
  • Article 44 Identification numbers and lists of notified bodies
  • Article 45 Changes to notifications
  • Article 46 Challenge of the competence of notified bodies
  • Article 47 Operational obligations of notified bodies
  • Article 48 Appeal against decisions of notified bodies
  • Article 49 Information obligation on notified bodies
  • Article 50 Exchange of experience
  • Article 51 Coordination of notified bodies
CHAPTER V MARKET SURVEILLANCE AND ENFORCEMENT
⊞ ▼
  • Article 52 Market surveillance and control of products with digital elements in the Union market
  • Article 53 Access to data and documentation
  • Article 54 Procedure at national level concerning products with digital elements presenting a significant cybersecurity risk
  • Article 55 Union safeguard procedure
  • Article 56 Procedure at Union level concerning products with digital elements presenting a significant cybersecurity risk
  • Article 57 Compliant products with digital elements which present a significant cybersecurity risk
  • Article 58 Formal non-compliance
  • Article 59 Joint activities of market surveillance authorities
  • Article 60 Sweeps
CHAPTER VI DELEGATED POWERS AND COMMITTEE PROCEDURE
⊞ ▼
  • Article 61 Exercise of the delegation
  • Article 62 Committee procedure
CHAPTER VII CONFIDENTIALITY AND PENALTIES
⊞ ▼
  • Article 63 Confidentiality
  • Article 64 Penalties
  • Article 65 Representative actions
CHAPTER VIII TRANSITIONAL AND FINAL PROVISIONS
⊞ ▼
  • Article 66 Amendment to Regulation (EU) 2019/1020
  • Article 67 Amendment to Directive (EU) 2020/1828
  • Article 68 Amendment to Regulation (EU) No 168/2013
  • Article 69 Transitional provisions
  • Article 70 Evaluation and review
  • Article 71 Entry into force and application
Annexes
▼
  • Annex I ESSENTIAL CYBERSECURITY REQUIREMENTS
  • Annex II INFORMATION AND INSTRUCTIONS TO THE USER
  • Annex III IMPORTANT PRODUCTS WITH DIGITAL ELEMENTS
  • Annex IV CRITICAL PRODUCTS WITH DIGITAL ELEMENTS
  • Annex V EU DECLARATION OF CONFORMITY
  • Annex VI SIMPLIFIED EU DECLARATION OF CONFORMITY
  • Annex VII CONTENT OF THE TECHNICAL DOCUMENTATION
  • Annex VIII CONFORMITY ASSESSMENT PROCEDURES
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