Requirement

Article 43.3: Conformity assessment procedure for providers of high-risk AI systems covered by EU harmonisation legislation

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For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider shall follow the relevant conformity assessment procedure as required under those legal acts. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point 4.6 of Annex VII shall also apply.

For the purposes of that assessment, notified bodies which have been notified under those legal acts shall be entitled to control the conformity of the high-risk AI systems with the requirements set out in Section 2, provided that the compliance of those notified bodies with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure under those legal acts.

Where a legal act listed in Section A of Annex I enables the product manufacturer to opt out from a third-party conformity assessment, provided that that manufacturer has applied all harmonised standards covering all the relevant requirements, that manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter.

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Article 43.3: Conformity assessment procedure for providers of high-risk AI systems covered by EU harmonisation legislation
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Article 43.3: Conformity assessment procedure for providers of high-risk AI systems covered by EU harmonisation legislation
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For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider shall follow the relevant conformity assessment procedure as required under those legal acts. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point 4.6 of Annex VII shall also apply.

For the purposes of that assessment, notified bodies which have been notified under those legal acts shall be entitled to control the conformity of the high-risk AI systems with the requirements set out in Section 2, provided that the compliance of those notified bodies with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure under those legal acts.

Where a legal act listed in Section A of Annex I enables the product manufacturer to opt out from a third-party conformity assessment, provided that that manufacturer has applied all harmonised standards covering all the relevant requirements, that manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter.

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Article 43.3: Conformity assessment procedure for providers of high-risk AI systems covered by EU harmonisation legislation
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How to comply with this requirement

In Cyberday, requirements and controls are mapped to universal tasks. Each requirement is fulfilled with one or multiple tasks.

Here's a list of tasks that help you comply with the requirement
Article 43.3: Conformity assessment procedure for providers of high-risk AI systems covered by EU harmonisation legislation
of the framework  
AI Act (Base)
Task name
Priority
Task completes
Complete these tasks to increase your compliance in this policy.
Critical
Process for conformity assessment of AI systems under existing legislation
Critical
High
Normal
Low
1
requirements
AI governance
AI risk and lifecycle management

Process for conformity assessment of AI systems under existing legislation

Completing this task also progresses your compliance in all of the following frameworks and requirements. Cyberday automatically maps completed tasks to all of these current and future frameworks - so you do not have to do it again!

Specific documentation for combined conformity assessments
Critical
High
Normal
Low
1
requirements
AI governance
AI risk and lifecycle management

Specific documentation for combined conformity assessments

Completing this task also progresses your compliance in all of the following frameworks and requirements. Cyberday automatically maps completed tasks to all of these current and future frameworks - so you do not have to do it again!

Selection of a Notified Body for combined assessments
Critical
High
Normal
Low
1
requirements
AI governance
AI risk and lifecycle management

Selection of a Notified Body for combined assessments

Completing this task also progresses your compliance in all of the following frameworks and requirements. Cyberday automatically maps completed tasks to all of these current and future frameworks - so you do not have to do it again!

Self-assessment using harmonised standards
Critical
High
Normal
Low
1
requirements
AI governance
AI risk and lifecycle management

Self-assessment using harmonised standards

Completing this task also progresses your compliance in all of the following frameworks and requirements. Cyberday automatically maps completed tasks to all of these current and future frameworks - so you do not have to do it again!

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Documented rules and practices that are created and maintained as a result of completing tasks.

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