subject
as defined in Regulation (EU) 2017/746 of the European Parliament and of the Council of…, Article 2, point (47) (Definitions)
(47)
‘subject’ means 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;
Install the extension for EUR-Lex
Also defined in
- AI Act 32024R1689, Article 3, point (58)
a natural person who participates in testing in real-world conditions - 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 - Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws… 32001L0020, Article 2, point (i)
an individual who participates in a clinical trial as either a recipient of the investigational medicinal product or a control;