Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58

Document information
Reference	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
Validity area	EU
Scope(s)	IVD
Document name	Regulation (EU) 2017/746 - in vitro diagnostic medical devices
Version / Revision	20-Mar-2023
Status	Current
Document type	Legal act
Language(s)	EN
Description	Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 1 — Unit 1.2.2
Scope	IVD
Document part	Article 2 Paragraph 58
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Informed consent, Definition, Performance study, Minor / Paediatric, Incapacitated subject, Legal representative
Comment	Definition of informed consent (IVD/performance study context)

Content

Definitions

(58) ‘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;