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Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 46: Difference between revisions

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Paragraph 46
Paragraph 46
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|tags_display=[[Glossary:TAG-00202-Inv-Pro|Investigational device]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]]
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{| class="wikitable gplx-infobox"
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! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| MD
|-
! Document part
| Article 2
Paragraph 46
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
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! Contributors
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! Tags (original language)
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|-
! Tags (FR)
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! Comment
| Definition of investigational device
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== Content ==
(46) ‘investigational device’ means a device that is assessed in a clinical investigation;

Latest revision as of 13:49, 16 July 2026



Document information
Reference EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
Validity area EU
Scope(s) MD
Document name Regulation (EU) 2017/745 - Medical Device Regulation
Version / Revision 20-Mar-2023
Status Current
Document type Legal act
Language(s) EN
Description REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 1 — Unit 1.2.2
Scope MD
Document part Article 2

Paragraph 46

Language EN
Original entry by Florian Adragna
Contributors
Tags Investigational device, Definition, Clinical investigation

Content

(46) ‘investigational device’ means a device that is assessed in a clinical investigation;

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