Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

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

From GxPlex

Jump to: navigation, search
← Older editNewer edit →
m 1 revision imported
imported>GxPlexBot
Import from GxPlex Excel
Line 5: Line 5:
Paragraph 1
Paragraph 1
|RefLanguage=EN
|RefLanguage=EN
|RefTagsEN=
|RefTags=TAG-00231-Per-ung ++ TAG-00245-Spo-ten ++ TAG-00246-Inv-hte ++ TAG-00232-Per-die
|RefTagsOriginal=
|RefModule=5
|RefTagsFR=
|RefUnit=5.4.3
}}
}}


Line 15: Line 15:
|-
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.4.3
|-
|-
! Scope
! Scope
Line 32: Line 35:
|  
|  
|-
|-
! Tags (EN)
! 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]]
|-
! Tags (original language)
|  
|-
! Tags (FR)
|  
|-
|-
! Comment
! Comment

Revision as of 17:29, 15 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
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.

Retrieved from "https://gxplex.org/index.php?title=Reference:EU_Regulation_(EU)_2017/746_-_in_vitro_diagnostic_medical_devices_20-Mar-2023_Article_68_Paragraph_1&oldid=15386"