Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 7 – 9

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 2 Paragraph 7 – 9
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Definition of companion diagnostic

Content

Definitions

(7) ‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to:

(a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or

(b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product;

(8) ‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

(9) ‘single-use device’ means a device that is intended to be used during a single procedure;