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Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

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, to promote innovation as well as competitiveness and growth in the single market. 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. A balanced representation of interests involving all relevant stakeholders in the development of standards, in particular SME’s, consumer organisations and environmental and social stakeholders in accordance with Article 5 and 6 of Regulation 1025/2012 should therefore be encouraged. In order to facilitate compliance, the standardisation requests should be issued by the Commission without undue delay. When preparing the standardisation request, the Commission should consult the AI advisory Forum and the Board in order to collect relevant expertise. However, in the absence of relevant references to harmonised standards, the Commission should be able to establish, via implementing acts, and after consultation of the AI Advisory forum, common specifications for certain requirements under this Regulation. The common specification should be an exceptional fall back solution to facilitate the provider’s obligation to comply with the requirements of this Regulation, when the standardisation request has not been accepted by any of the European standardisation organisations, or when the relevant harmonized standards insufficiently address fundamental rights concerns, or when the harmonised standards do not comply with the request, or when there are delays in the adoption of an appropriate harmonised standard. If such delay in the adoption of a harmonised standard 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. When developing common specifications, the Commission is encouraged to cooperate with international partners and international standardisation bodies.

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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.

25Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

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