subject
as defined in Directive 2001/20/EC of the European Parliament and of the Council of 4 April…, Article 2, point (i) (Definitions)
an individual who participates in a clinical trial as either a recipient of the investigational medicinal product or a control;
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Also defined in
- AI Act 32024R1689, Article 3, point (58)
a natural person who participates in testing in real-world conditions - 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 (47)
an individual who participates in a performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/or by a device used for control purposes - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending… 32017R0745, Article 2, point (50)
an individual who participates in a clinical investigation - Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on… 32014R0536, Article 2(2), point (17)
an individual who participates in a clinical trial, either as recipient of an investigational medicinal product or as a control