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(72)
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To address concerns related to opacity and complexity of certain AI systems
and help deployers to fulfil their obligations under this Regulation, transparency should be
required for high-risk AI systems before they are placed on the market or put it into service.
High-risk AI systems should be designed in a manner to enable deployers to understand how
the AI system works, evaluate its functionality, and comprehend its strengths and limitations.
High-risk AI systems should be accompanied by appropriate information in the form of
instructions of use. Such information should include the characteristics, capabilities and
limitations of performance of the AI system. Those would cover information on possible known and
foreseeable circumstances related to the use of the high-risk AI system, including deployer
action that may influence system behaviour and performance, under which the AI system can lead
to risks to health, safety, and fundamental rights, on the changes that have been pre-determined
and assessed for conformity by the provider and on the relevant human oversight measures,
including the measures to facilitate the interpretation of the outputs of the AI system by the
deployers. Transparency, including the accompanying instructions for use, should assist
deployers in the use of the system and support informed decision making by them. Deployers
should, inter alia, be in a better position to make the correct choice of the system that
they intend to use in light of the obligations applicable to them, be educated about the
intended and precluded uses, and use the AI system correctly and as appropriate. In order to
enhance legibility and accessibility of the information included in the instructions of use,
where appropriate, illustrative examples, for instance on the limitations and on the intended
and precluded uses of the AI system, should be included. Providers should ensure that all
documentation, including the instructions for use, contains meaningful, comprehensive,
accessible and understandable information, taking into account the needs and foreseeable
knowledge of the target deployers. Instructions for use should be made available in
a language which can be easily understood by target deployers, as determined by the Member
State concerned.
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