Informed consent

Consent has to be documented, and the subject can withdraw at any time without detriment. For minors and incapacitated subjects, a legally designated representative gives the authorisation.

‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation;

EU MDR, Article 2(55)

‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all aspects of the performance study that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the performance study;

IVDR, Article 2(58)

process by which an individual voluntarily confirms willingness to participate in a particular clinical investigation (3.8), after having been informed of all aspects of the investigation that are relevant to the decision to participate

ISO 14155:2020, clause 3.27