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Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 5: Difference between revisions

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Paragraph 5
Paragraph 5
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|comment=Member State inspection of performance studies
{{:Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023}}
|content=Conduct of a performance study
 
{| class="wikitable gplx-infobox"
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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Module
| Module 4 — Unit 4.5.2
|-
! Scope
| IVD
|-
! Document part
| Article 68
Paragraph 5
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
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| [[Glossary:TAG-00044-Ins-ion|Inspection]], [[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00135-Inv-ntr|Trial site]]
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| Member State inspection of performance studies
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== Content ==
Conduct of a performance study


5.  Member States shall inspect, at an appropriate level, performance study site(s) to check that performance studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
5.  Member States shall inspect, at an appropriate level, performance study site(s) to check that performance studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
}}

Revision as of 12:56, 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 — Unit 4.5.2
Scope IVD
Document part Article 68

Paragraph 5

Language EN
Original entry by Florian Adragna
Contributors
Tags Inspection, Performance study, Trial site

Content

Conduct of a performance study

5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.

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