Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 | ||
| | |module=1 | ||
| | |unit=1.3.0 | ||
|scope=MD | |||
|doc_part=ANNEX XV | |||
Chapter III, 6 | Chapter III, 6 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |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]] | |||
|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.
