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TURKISH ACCREDITATION AGENCY
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Informed Consent


Use: In vitro diagnostic medical devices; Medical devices; Medicine

Source: Regulation (EU) 2017/746 on in vitro diagnostic medical devices

Explanation:

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 authoris ation or agreement from their legally designated representative to include them in the performance study