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Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 45: Difference between revisions

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Document part
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Paragraph 45
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| EN
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== Content ==
Definitions


(45) β€˜device for performance study’ means a device intended by the manufacturer to be used in a performance study.
(45) β€˜device for performance study’ means a device intended by the manufacturer to be used in a performance study.
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Latest revision as of 13:49, 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 45

Language EN
Original entry by Florian Adragna
Contributors
Tags Investigational IVD, Performance study, Definition

Content

Definitions

(45) β€˜device for performance study’ means a device intended by the manufacturer to be used in a performance study.

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