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Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter I Section 1.8: Difference between revisions

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{{#set:
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|has_document=Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
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Chapter I
Chapter I
Section 1.8
Section 1.8
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|entry_by=Florian Adragna
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|tags=TAG-00343-Doc-ten ++ TAG-00231-Per-ung ++ TAG-00235-Int-stu ++ TAG-00176-Ris-erh
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|tags_display=[[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00235-Int-stu|Interventional performance study]], [[Glossary:TAG-00176-Ris-erh|Risk]]
 
|comment=Documentation required for performance study application
{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}}
|content=DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES
 
{| class="gplx-infobox"
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! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| IVD
|-
! Document part
| Annex XIV
Chapter I
Section 1.8
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
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|-
! Tags (original language)
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! Tags (FR)
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| Documentation required for performance study application
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== Content ==
DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES


For devices intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects of the studies, the sponsor shall draw up and submit the application in accordance with Article 58 accompanied by the following documents:
For devices intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects of the studies, the sponsor shall draw up and submit the application in accordance with Article 58 accompanied by the following documents:
Line 54: Line 19:


1.8. if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;
1.8. if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;
}}

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 1 — Unit 1.5.4
Scope IVD
Document part Annex XIV

Chapter I Section 1.8

Language EN
Original entry by Florian Adragna
Contributors
Tags Documentation, Performance study, Interventional performance study, Risk

Content

DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES

For devices intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects of the studies, the sponsor shall draw up and submit the application in accordance with Article 58 accompanied by the following documents: […]

1.8. if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;

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