|
(64)
|
To mitigate the risks from high-risk AI systems placed on the market or put
into service and to ensure a high level of trustworthiness, certain mandatory requirements
should apply to high-risk AI systems, taking into account the intended purpose and the context
of use of the AI system and according to the risk-management system to be established by the
provider. The measures adopted by the providers to comply with the mandatory requirements of
this Regulation should take into account the generally acknowledged state of the art on AI, be
proportionate and effective to meet the objectives of this Regulation. Based on the New
Legislative Framework, as clarified in Commission notice ‘The “Blue Guide” on the implementation
of EU product rules 2022’, the general rule is that more than one legal act of Union
harmonisation legislation may be applicable to one product, since the making available or
putting into service can take place only when the product complies with all applicable Union
harmonisation legislation. The hazards of AI systems covered by the requirements of this
Regulation concern different aspects than the existing Union harmonisation legislation and
therefore the requirements of this Regulation would complement the existing body of the Union
harmonisation legislation. For example, machinery or medical devices products incorporating an
AI system might present risks not addressed by the essential health and safety requirements set
out in the relevant Union harmonised legislation, as that sectoral law does not deal with risks
specific to AI systems. This calls for a simultaneous and complementary application of the
various legislative acts. To ensure consistency and to avoid an unnecessary administrative
burden and unnecessary costs, providers of a product that contains one or more high-risk AI
system, to which the requirements of this Regulation and of the Union harmonisation legislation
based on the New Legislative Framework and listed in an annex to this Regulation apply, should
have flexibility with regard to operational decisions on how to ensure compliance of
a product that contains one or more AI systems with all the applicable requirements of that
Union harmonised legislation in an optimal manner. That flexibility could mean, for example
a decision by the provider to integrate a part of the necessary testing and reporting
processes, information and documentation required under this Regulation into already existing
documentation and procedures required under existing Union harmonisation legislation based on
the New Legislative Framework and listed in an annex to this Regulation. This should not, in any
way, undermine the obligation of the provider to comply with all the applicable requirements.
|