(51)
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The classification of an AI system as high-risk pursuant to this Regulation
should not necessarily mean that the product whose safety component is the AI system, or the AI
system itself as a product, is considered to be high-risk under the criteria established in
the relevant Union harmonisation legislation that applies to the product. This is, in
particular, the case for Regulations (EU) 2017/745 and (EU) 2017/746, where a third-party
conformity assessment is provided for medium-risk and high-risk products.
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