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Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42: Difference between revisions

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== 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 ==
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! scope="row" style="width:200px;" | Scope
! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| IVD
| IVD
|-
|-
! scope="row" style="width:200px;" | Document part
! Document part
| Article 2  
| Article 2  
Paragraph 42
Paragraph 42
|-
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! 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)
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|-
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! scope="row" style="width:200px;" | Tags (original language)
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|-
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! scope="row" style="width:200px;" | Tags (FR)
! Tags (FR)
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|  
|-
|-
! scope="row" | Comment
! Comment
| Definition of performance study
| Definition of performance study
|}
|}


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


(42) ‘performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;
(42) ‘performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;

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 42

Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Definition of performance study

Content

Definitions

(42) ‘performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;

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