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Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 1.12: Difference between revisions

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Chapter II
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Section 1.12
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{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}}
{| class="gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| IVD
|-
! Document part
| Annex XIV
Chapter II
Section 1.12
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
|
|-
! Tags (FR)
|
|-
! Comment
| Comparator device requirements in clinical investigation
|}
== Content ==
1.12. if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device;

Latest revision as of 13:49, 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 2 — Unit 2.3.2
Scope IVD
Document part Annex XIV

Chapter II Section 1.12

Language EN
Original entry by Florian Adragna
Contributors
Tags Comparator, Clinical investigation, Medical device, Requirements

Content

1.12. if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device;

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