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Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6: Difference between revisions

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|has_document=Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
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Chapter III, 6
Chapter III, 6
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|tags=TAG-00043-Goo-tek ++ TAG-00044-Ins-ion ++ TAG-00017-Spo-die ++ TAG-00201-Cli-eSt
|tags_display=[[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00044-Ins-ion|Inspection]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]]
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{{:Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023}}
{| class="gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| MD
|-
! Document part
| ANNEX XV
Chapter III, 6
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
|
|-
! Tags (FR)
|
|-
! Comment
| Requirement for evidence of GCP compliance in the investigation
|}
== Content ==
6. The Sponsor shall provide evidence that the investigation is being conducted in line with good clinical practice, for instance through internal or external inspection.

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 1.3.0
Scope MD
Document part ANNEX XV

Chapter III, 6

Language EN
Original entry by Florian Adragna
Contributors
Tags Good clinical practice, Inspection, Sponsor, Clinical investigation

Content

6. The Sponsor shall provide evidence that the investigation is being conducted in line with good clinical practice, for instance through internal or external inspection.

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