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Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 2: Difference between revisions

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{{#set:
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Paragraph 2
Paragraph 2
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|tags_display=[[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00231-Per-ung|Performance study]], [[Glossary:TAG-00329-Saf-lne|Safety]], [[Glossary:TAG-00220-Inv-agn|IVD]]
 
|comment=Monitoring obligations in performance study (IVDR)
{{: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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| IVD
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! Document part
| Article 68
Paragraph 2
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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== Content ==
Conduct of a performance study


2.  In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the performance study including the following:
2.  In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the performance study including the following:
Line 53: Line 19:


(b) the degree of deviation of the intervention from normal clinical practice.
(b) the degree of deviation of the intervention from normal clinical practice.
}}

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 — Unit 4.3.1
Scope IVD
Document part Article 68

Paragraph 2

Language EN
Original entry by Florian Adragna
Contributors
Tags Monitoring, Sponsor responsibilities, Performance study, Safety, IVD

Content

Conduct of a performance study

2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the performance study including the following:

(a) the objective and methodology of the performance study; and

(b) the degree of deviation of the intervention from normal clinical practice.

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