Subject

The rights, safety and informed consent of subjects sit at the center of clinical investigation rules in both the EU and the US.

‘subject’ means an individual who participates in a clinical investigation;

EU MDR, Article 2(50)

‘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;

IVDR, Article 2(47)

Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.

21 CFR, 812.3

individual who is or becomes a participant in a clinical investigation (3.8), either as a recipient of the investigational device or a comparator (3.12) Note 1 to entry: This includes healthy volunteers.

ISO 14155:2020, clause 3.50

In general, for the purposes of this guidance, the use of the term “patient” refers to an individual who is under medical care or treatment and is not a subject, and the use of the term “subject” refers to an individual who participates in a clinical investigation.

FDA guidance: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (August 2019), Footnote 7

The IVDR definition ties the subject to specimens examined in a performance study. 21 CFR 812.3 includes people in normal health and people used as controls, and FDA's benefit-risk guidance separates a subject in an investigation from a patient under care.