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AI systems could have an adverse impact on the health and safety of persons,
in particular when such systems operate as safety components of products. Consistent with the
objectives of Union harmonisation legislation to facilitate the free movement of products in the
internal market and to ensure that only safe and otherwise compliant products find their way
into the market, it is important that the safety risks that may be generated by a product
as a whole due to its digital components, including AI systems, are duly prevented and
mitigated. For instance, increasingly autonomous robots, whether in the context of manufacturing
or personal assistance and care should be able to safely operate and performs their functions in
complex environments. Similarly, in the health sector where the stakes for life and health are
particularly high, increasingly sophisticated diagnostics systems and systems supporting human
decisions should be reliable and accurate.
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