Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4: Difference between revisions

From GxPlex

Jump to: navigation, search
← Older editNewer edit →
gxplex>GxPlexBot
Import from GxPlex Excel
Migrate to Template:ReferenceData for PageForms (GxPlexBot)
Line 1: Line 1:
{{#set:
{{ReferenceData
|HasDocument=Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
|has_document=Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
|RefScope=MD
|module=4
|RefDocPart=Annex XV
|unit=4.3.1
|scope=MD
|doc_part=Annex XV
Chapter III
Chapter III
Section 4
Section 4
|RefLanguage=EN
|language=EN
|RefTags=TAG-00020-Cli-nit ++ TAG-00245-Spo-ten ++ TAG-00203-Cli-lin ++ TAG-00043-Goo-tek ++ TAG-00155-Med-Med
|entry_by=Florian Adragna
|RefModule=4
|contributors=
|RefUnit=4.3.1
|tags=TAG-00020-Cli-nit ++ TAG-00245-Spo-ten ++ TAG-00203-Cli-lin ++ TAG-00043-Goo-tek ++ TAG-00155-Med-Med
}}
|tags_display=[[Glossary:TAG-00020-Cli-nit|CRA / Monitor]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00203-Cli-lin|Investigation plan]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00155-Med-Med|Medical device]]
 
|comment=Sponsor obligation to appoint independent monitor
{{:Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023}}
|content=OTHER OBLIGATIONS OF THE SPONSOR
 
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 4 — Unit 4.3.1
|-
! Scope
| MD
|-
! Document part
| Annex XV
Chapter III
Section 4
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00020-Cli-nit|CRA / Monitor]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00203-Cli-lin|Investigation plan]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00155-Med-Med|Medical device]]
|-
! Comment
| Sponsor obligation to appoint independent monitor
|}
 
== Content ==
OTHER OBLIGATIONS OF THE SPONSOR


4.  The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the investigation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation.
4.  The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the investigation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation.
}}

Revision as of 12:56, 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 4 — Unit 4.3.1
Scope MD
Document part Annex XV

Chapter III Section 4

Language EN
Original entry by Florian Adragna
Contributors
Tags CRA / Monitor, Sponsor responsibilities, Investigation plan, Good clinical practice, Medical device

Content

OTHER OBLIGATIONS OF THE SPONSOR

4. The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the investigation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation.

Retrieved from "https://gxplex.org/index.php?title=Reference:EU_Regulation_(EU)_2017/745_-_Medical_Device_Regulation_20-Mar-2023_Annex_XV_Chapter_III_Section_4&oldid=16820"