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Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 6: Difference between revisions

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{{#set:
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|has_document=Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
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|RefDocPart=Article 72
|unit=5.4.3
|scope=MD
|doc_part=Article 72
Paragraph 6
Paragraph 6
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|language=EN
|RefTags=TAG-00069-Imm-rhe ++ TAG-00211-Rec-ukt ++ TAG-00017-Spo-die ++ TAG-00202-Inv-Pro ++ TAG-00201-Cli-eSt
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|tags_display=[[Glossary:TAG-00069-Imm-rhe|Urgent safety measure]], [[Glossary:TAG-00211-Rec-ukt|Product recall]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00202-Inv-Pro|Investigational device]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]]
 
|comment=Sponsor obligation to establish emergency procedure for identification and recall of investigational devices
{{:Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023}}
|content=Conduct of a clinical investigation
 
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.4.3
|-
! Scope
| MD
|-
! Document part
| Article 72
Paragraph 6
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00069-Imm-rhe|Urgent safety measure]], [[Glossary:TAG-00211-Rec-ukt|Product recall]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00202-Inv-Pro|Investigational device]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]]
|-
! Comment
| Sponsor obligation to establish emergency procedure for identification and recall of investigational devices
|}
 
== Content ==
Conduct of a clinical investigation


6.  The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the investigation.
6.  The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the investigation.
}}

Latest revision as of 13:50, 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 5 — Unit 5.4.3
Scope MD
Document part Article 72

Paragraph 6

Language EN
Original entry by Florian Adragna
Contributors
Tags Urgent safety measure, Product recall, Sponsor, Investigational device, Clinical investigation

Content

Conduct of a clinical investigation

6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the investigation.

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