aiact/history/commission-2021 · 2021-04-21 · COM(2021) 206 final
Articles (84)
- 1 — Subject matter
- 2 — Scope
- 3 — Definitions
- 4 — Amendments to Annex I
- 5 — 1.
- 6 — Classification rules for high-risk AI systems
- 7 — Amendments to Annex III
- 8 — Compliance with the requirements
- 9 — Risk management system
- 10 — Data and data governance
- 11 — Technical documentation
- 12 — Record-keeping
- 13 — Transparency and provision of information to users
- 14 — Human oversight
- 15 — Accuracy, robustness and cybersecurity
- 16 — Obligations of providers of high-risk AI systems
- 17 — Quality management system
- 18 — Obligation to draw up technical documentation
- 19 — Conformity assessment
- 20 — Automatically generated logs
- 21 — Corrective actions
- 22 — Duty of information
- 23 — Cooperation with competent authorities
- 24 — Obligations of product manufacturers
- 25 — Authorised representatives
- 26 — Obligations of importers
- 27 — Obligations of distributors
- 28 — Obligations of distributors, importers, users or any other third-party
- 29 — Obligations of users of high-risk AI systems
- 30 — Notifying authorities
- 31 — Application of a conformity assessment body for notification
- 32 — Notification procedure
- 33 — Notified bodies
- 34 — Subsidiaries of and subcontracting by notified bodies
- 35 — Identification numbers and lists of notified bodies designated under this Regulation
- 36 — Changes to notifications
- 37 — Challenge to the competence of notified bodies
- 38 — Coordination of notified bodies
- 39 — Conformity assessment bodies of third countries
- 40 — Harmonised standards
- 41 — Common specifications
- 42 — Presumption of conformity with certain requirements
- 43 — Conformity assessment
- 44 — Certificates
- 45 — Appeal against decisions of notified bodies
- 46 — Information obligations of notified bodies
- 47 — Derogation from conformity assessment procedure
- 48 — EU declaration of conformity
- 49 — CE marking of conformity
- 50 — Document retention
- 51 — The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51.
- 52 — Transparency obligations for certain AI systems
- 53 — AI regulatory sandboxes
- 54 — Further processing of personal data
- 55 — Measures for small-scale providers and users
- 56 — Establishment of the
- 57 — Structure of the Board
- 58 — Tasks of the Board
- 59 — Designation of national competent authorities
- 60 — EU database for stand-alone high-risk AI systems
- 61 — Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
- 62 — Reporting of serious incidents and of malfunctioning
- 63 — Market surveillance and control of AI systems in the Union market
- 64 — Access to data and documentation
- 66 — Union safeguard procedure
- 67 — Compliant AI systems which present a risk
- 68 — Formal non-compliance
- 69 — Codes of conduct
- 70 — Confidentiality
- 71 — Penalties
- 72 — Administrative fines on Union institutions, agencies and
- 73 — Exercise of the delegation
- 74 — Committee procedure
- 75 — Amendment to Regulation (EC) No 300/2008
- 76 — Amendment to Regulation (EU) No 167/2013
- 77 — Amendment to Regulation (EU) No 168/2013
- 78 — Amendment to Directive 2014/90/EU
- 79 — Amendment to Directive (EU) 2016/797
- 80 — Amendment to Regulation (EU) 2018/858
- 81 — Amendment to Regulation (EU) 2018/1139
- 82 — Amendment to Regulation (EU) 2019/2144
- 83 — AI systems already placed on the market or put into service
- 84 — Evaluation and review
- 85 — Entry into force and application