Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6: Difference between revisions
From GxPlex
Gxplex admin (talk | contribs) m 1 revision imported |
gxplex>GxPlexBot Import from GxPlex Excel |
||
| Line 10: | Line 10: | ||
}} | }} | ||
{{:Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023}} | {{:Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023}} | ||
{| class="gplx-infobox" | |||
{| class=" | |||
|- | |- | ||
! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| MD | | MD | ||
|- | |- | ||
! | ! Document part | ||
| ANNEX XV | | ANNEX XV | ||
Chapter III, 6 | Chapter III, 6 | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
| | | | ||
|- | |- | ||
! | ! Tags (original language) | ||
| | | | ||
|- | |- | ||
! | ! Tags (FR) | ||
| | | | ||
|- | |- | ||
! | ! Comment | ||
| Requirement for evidence of GCP compliance in the investigation | | 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. | 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. | ||
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 | 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.
