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Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4: Difference between revisions

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{{#set:
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|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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Chapter II
Chapter II
SectionΒ  4
SectionΒ  4
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|tags_display=[[Glossary:TAG-00020-Cli-nit|CRA / Monitor]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00232-Per-die|Performance study plan]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00231-Per-ung|Performance study]]
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|comment=Sponsor obligation to appoint monitor (performance study)
{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}}
|content=OTHER OBLIGATIONS OF THE SPONSOR
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{| class="wikitable gplx-infobox"
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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| IVD
|-
! Document part
| Annex XIV
Chapter II
SectionΒ  4
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
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! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
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! Tags (FR)
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| Sponsor obligation to appoint monitor (performance study)
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== Content ==
OTHER OBLIGATIONS OF THE SPONSOR


4. The sponsor shall appoint a monitor that is independent of the investigation site to ensure that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the principles of good clinical practice and this Regulation.
4. The sponsor shall appoint a monitor that is independent of the investigation site to ensure that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the principles of good clinical practice and this Regulation.
}}

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 4 β€” Unit 4.3.1
Scope IVD
Document part Annex XIV

Chapter II Section 4

Language EN
Original entry by Florian Adragna
Contributors
Tags CRA / Monitor, Sponsor responsibilities, Performance study plan, Good clinical practice, Performance study

Content

OTHER OBLIGATIONS OF THE SPONSOR

4. The sponsor shall appoint a monitor that is independent of the investigation site to ensure that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the principles of good clinical practice and this Regulation.

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