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Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 1: Difference between revisions

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{{#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
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|unit=5.4.3
|scope=IVD
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Paragraph 1
Paragraph 1
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|tags=TAG-00231-Per-ung ++ TAG-00245-Spo-ten ++ TAG-00246-Inv-hte ++ TAG-00232-Per-die
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|tags_display=[[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00232-Per-die|Performance study plan]]
 
|comment=Sponsor and investigator obligations in performance study conduct
{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}}
|content=Conduct of a performance study
 
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.4.3
|-
! Scope
| IVD
|-
! Document part
| Article 68
Paragraph 1
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00232-Per-die|Performance study plan]]
|-
! Comment
| Sponsor and investigator obligations in performance study conduct
|}
 
== Content ==
Conduct of a performance study


1.  The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study plan.
1.  The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study plan.
}}

Latest revision as of 13:50, 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 5 — Unit 5.4.3
Scope IVD
Document part Article 68

Paragraph 1

Language EN
Original entry by Florian Adragna
Contributors
Tags Performance study, Sponsor responsibilities, Investigator responsibilities, Performance study plan

Content

Conduct of a performance study

1. The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study plan.

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