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 →
gxplex>GxPlexBot
Import from GxPlex Excel
Migrate to Template:ReferenceData for PageForms (GxPlexBot)
Line 1: Line 1:
{{#set:
{{ReferenceData
|HasDocument=Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
|has_document=Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
|RefScope=IVD
|module=1
|RefDocPart=Article 2  
|unit=1.2.2
|scope=IVD
|doc_part=Article 2  
Paragraph 7 – 9
Paragraph 7 – 9
|RefLanguage=EN
|language=EN
|RefTags=TAG-00225-Com-nos ++ TAG-00161-Gen-rup ++ TAG-00162-Sin-tik ++ TAG-00244-Def-ini ++ TAG-00001-Med-rzn
|entry_by=Florian Adragna
|RefModule=1
|contributors=
|RefUnit=1.2.2
|tags=TAG-00225-Com-nos ++ TAG-00161-Gen-rup ++ TAG-00162-Sin-tik ++ TAG-00244-Def-ini ++ TAG-00001-Med-rzn
}}
|tags_display=[[Glossary:TAG-00225-Com-nos|Companion diagnostic]], [[Glossary:TAG-00161-Gen-rup|Device group]], [[Glossary:TAG-00162-Sin-tik|Single-use device]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00001-Med-rzn|Medicinal product]]
 
|comment=Definition of companion diagnostic
{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}}
|content=Definitions
 
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 1 — Unit 1.2.2
|-
! Scope
| IVD
|-
! Document part
| Article 2
Paragraph 7 – 9
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00225-Com-nos|Companion diagnostic]], [[Glossary:TAG-00161-Gen-rup|Device group]], [[Glossary:TAG-00162-Sin-tik|Single-use device]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00001-Med-rzn|Medicinal product]]
|-
! 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:
(7) ‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to:
Line 54: Line 23:


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

Revision as of 12:54, 16 July 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
Module Module 1 — Unit 1.2.2
Scope IVD
Document part Article 2

Paragraph 7 – 9

Language EN
Original entry by Florian Adragna
Contributors
Tags Companion diagnostic, Device group, Single-use device, Definition, Medicinal product

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=16083"