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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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== Document Information ==
{{:Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023}}
{{:Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023}}


== Reference Details ==
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| MD
| MD
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! scope="row" style="width:200px;" | Document part
! Document part
| Article 2
| Article 2
Paragraph 46
Paragraph 46
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! scope="row" style="width:200px;" | Language
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| EN
| EN
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! scope="row" style="width:200px;" | Original entry by
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| Florian Adragna
| Florian Adragna
|-
|-
! scope="row" style="width:200px;" | Contributors
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|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (EN)
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! scope="row" style="width:200px;" | Tags (original language)
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! scope="row" style="width:200px;" | Tags (FR)
! Tags (FR)
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|-
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! scope="row" | Comment
! Comment
| Definition of investigational device
| Definition of investigational device
|}
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== Text ==
== Content ==
(46) ‘investigational device’ means a device that is assessed in a clinical investigation;
(46) ‘investigational device’ means a device that is assessed in a clinical investigation;

Revision as of 14:27, 29 June 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
Scope MD
Document part Article 2

Paragraph 46

Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Definition of investigational device

Content

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

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