Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1

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
Scope	IVD
Document part	Article 76 Paragraph 1
Language	EN
Original entry by	Florian Adragna
Contributors
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Comment	Recording and reporting AEs in performance studies

Content

Recording and reporting of adverse events that occur during performance studies

1. The sponsor shall fully record all of the following:

(a) any adverse event of a type identified in the performance study plan as being critical to the evaluation of the results of that performance study;

(b) any serious adverse event;

(c) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;

(d) any new findings in relation to any event referred to in points (a) to (c).