Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

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

From GxPlex

Jump to: navigation, search
← Older editNewer edit →
m 1 revision imported
gxplex>GxPlexBot
Import from GxPlex Excel
Line 10: Line 10:
}}
}}


== Document Information ==
{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}}
{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}}


== Reference Details ==
{| class="gplx-infobox"
{| class="wikitable" style="width:100%;"
|-
|-
! scope="row" style="width:200px;" | Scope
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| IVD
| IVD
|-
|-
! scope="row" style="width:200px;" | Document part
! Document part
| Article 2  
| Article 2  
Paragraph 7 – 9
Paragraph 7 – 9
|-
|-
! scope="row" style="width:200px;" | Language
! Language
| EN
| EN
|-
|-
! scope="row" style="width:200px;" | Original entry by
! Original entry by
| Florian Adragna
| Florian Adragna
|-
|-
! scope="row" style="width:200px;" | Contributors
! Contributors
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (EN)
! Tags (EN)
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (original language)
! Tags (original language)
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (FR)
! Tags (FR)
|  
|  
|-
|-
! scope="row" | Comment
! Comment
| Definition of companion diagnostic
| Definition of companion diagnostic
|}
|}


== Text ==
== Content ==
Definitions
Definitions


Revision as of 14:27, 29 June 2026



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;

Retrieved from "https://gxplex.org/index.php?title=Reference:EU_Regulation_(EU)_2017/746_-_in_vitro_diagnostic_medical_devices_20-Mar-2023_Article_2_Paragraph_7_–_9&oldid=6626"