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Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42: Difference between revisions

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Document part
| Article 2
Paragraph 42
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| EN
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== Content ==
Definitions


(42) β€˜performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;
(42) β€˜performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;
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Revision as of 12:54, 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 1 β€” Unit 1.2.2
Scope IVD
Document part Article 2

Paragraph 42

Language EN
Original entry by Florian Adragna
Contributors
Tags Performance study, Definition, Device performance (IVDR)

Content

Definitions

(42) β€˜performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;

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