subject
Defined in 4 EU acts of the All group: Clinical Trials Regulation First MDR Own wording IVDR Own wording AI Act Own wording ≠
Clinical Trials Regulation, Article 2(2)(17) First adopted 2014-04-16
an individual who participates in a clinical trial, either as recipient of an investigational medicinal product or as a controlMDR, Article 2(50) Own wording adopted 2017-04-05
an individual who participates in a clinical trial, either as recipient of an investigational medicinal product or as a control investigation
Compared with Clinical Trials Regulation: struck words are only in Clinical Trials Regulation, marked words only here.
IVDR, Article 2(47) Own wording adopted 2017-04-05
an individual who participates in a clinical trial, either as recipient of an investigational medicinal product performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/ or as by a device used for control purposes
Compared with Clinical Trials Regulation: struck words are only in Clinical Trials Regulation, marked words only here.
AI Act, Article 3(58) Own wording adopted 2024-06-13
Possibly a different concept.
an individual for the purpose of real-world testing, a natural person who participates in a clinical trial, either as recipient of an investigational medicinal product or as a control testing in real-world conditions
Compared with Clinical Trials Regulation: struck words are only in Clinical Trials Regulation, marked words only here.