instructions for use
as defined in Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING…, Article 3, point (15) (Definitions)
the information provided by the provider to inform the user of in particular an AI system’s intended purpose and proper use, inclusive of the specific geographical, behavioural or functional setting within which the high-risk AI system is intended to be used
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Also defined in
- Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data… 32025R0327, Article 2(1), point (e)
laid down in Article 2, points (1), (12), (14), (22), (36) and (71), respectively, of Regulation (EU) 2017/745 - AI Act 32024R1689, Article 3, point (15)
the information provided by the provider to inform the deployer of, in particular, an AI system’s intended purpose and proper use - Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing… 32023R1230, Article 3, point (17)
the information, provided by the manufacturer when the machinery or related product is placed on the market or put into service, to inform the user of the machinery or related product, of the intended and proper use of that machinery or related product, as well as information on any precautions to… - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical… 32017R0746, Article 2, point (14)
the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending… 32017R0745, Article 2, point (14)
the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken