Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter II Section 1.7: 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=1.5.4 | ||
|scope=MD | |||
|doc_part=Annex XV | |||
Chapter II | Chapter II | ||
Section 1.7 | Section 1.7 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00343-Doc-ten ++ TAG-00201-Cli-eSt ++ TAG-00202-Inv-Pro ++ TAG-00017-Spo-die | |||
|tags_display=[[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00202-Inv-Pro|Investigational device]], [[Glossary:TAG-00017-Spo-die|Sponsor]] | |||
|comment=Documentation required for clinical investigation application (device) | |||
|content=DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION | |||
| | |||
| | |||
= | |||
DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION | |||
For investigational devices covered by Article 62, the sponsor shall draw up and submit the application in accordance with Article 70 accompanied by the following documents: | For investigational devices covered by Article 62, the sponsor shall draw up and submit the application in accordance with Article 70 accompanied by the following documents: | ||
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1.7. if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial; | 1.7. if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial; | ||
}} | |||
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 1.5.4 |
| Scope | MD |
| Document part | Annex XV
Chapter II Section 1.7 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Documentation, Clinical investigation, Investigational device, Sponsor |
Content
DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION
For investigational devices covered by Article 62, the sponsor shall draw up and submit the application in accordance with Article 70 accompanied by the following documents:
1. Application form
The application form shall be duly filled in, containing information regarding: [...]
1.7. if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;
