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Recital 61

Harmonised Standards

Standardisation should play a key role to provide technical solutions to providers to ensure compliance with this Regulation, in line with the state of the art. Compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council25, which are normally expected to reflect the state of the art,should be a means for providers to demonstrate conformity with the requirements of this Regulation. However, in the absence of relevant references to harmonised standards, the Commission should be able to establish, via implementing acts, common specifications for certain requirements under this Regulation as an exceptional fall back solution to facilitate the provider’s obligation to comply with the requirements of this Regulation, when the standardisation process is blocked or when there are delays in the establishment of an appropriate harmonised standard. If such delay is due to the technical complexity of the standard in question, this should be considered by the Commission before contemplating the establishment of common specifications. An appropriate involvement of small and medium enterprises in the elaboration of standards supporting the implementation of this Regulation is essential to promote innovation and competitiveness in the field of artificial intelligence within the Union. Such involvement should be appropriately ensured in accordance with Article 5 and 6 of Regulation 1025/2012.

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