intended purpose
as defined in Regulation (EU) 2017/745 of the European Parliament and of the Council of…, Article 2, point (12) (Definitions)
(12)
‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;
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Also defined in
- Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on horizontal cybersecurity requirements for… 52022PC0454, Article 3, point (24)
the use for which a product with digital elements is intended by the manufacturer, including the specific context and conditions of use, as specified in the information supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the… - Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL… 52021PC0206, Article 3, point (12)
the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation - 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 - Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity… 32024R2847, Article 3, point (23)
the use for which a product with digital elements is intended by the manufacturer, including the specific context and conditions of use, as specified in the information supplied by the manufacturer in the instructions for use, promotional or sales materials and statements, as well as in the… - AI Act 32024R1689, Article 3, point (12)
the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation - 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 (12)
the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical… 31998L0079, Article 1(2), point (h)
the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials; - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 31993L0042, Article 1(2), point (g)
the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active… 31990L0385, Article 1(2), point (f)
the use for which the medical device is intended and for which it is suited according to the data supplied by the manufacturer in the instructions